Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2026-01-01 @ 10:51 AM
Study NCT ID:
NCT00840632
Status:
COMPLETED
Last Update Posted:
2024-08-20
First Post:
2009-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trandolapril 4 mg Tablet Under Fasting Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C052035', 'term': 'trandolapril'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrialqueries@tevausa.com', 'phone': '1-866-384-5525', 'title': 'Manager, Biopharmaceutics', 'organization': 'Teva Pharmaceuticals USA'}, 'certainAgreement': {'otherDetails': 'Principal Investigator is not permitted to discuss or publish trial results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cmax - Maximum Observed Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trandolapril', 'description': 'Trandolapril 4 mg Tablet (test) dosed in either period'}, {'id': 'OG001', 'title': 'Mavik®', 'description': 'Mavik® 4 mg Tablet (reference) dosed in either period'}], 'classes': [{'categories': [{'measurements': [{'value': '4559.54', 'spread': '2269.88', 'groupId': 'OG000'}, {'value': '4872.59', 'spread': '2218.00', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Least Squares Means', 'ciPctValue': '90', 'paramValue': '93.26', 'ciLowerLimit': '83.39', 'ciUpperLimit': '104.31', 'estimateComment': 'Bioequivalence is established when 90% Confidence Interval falls within 80-125.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over 24 hour period', 'description': 'Bioequivalence based on Cmax', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from all subjects who completed the study were included in the statistical analysis.', 'anticipatedPostingDate': '2009-07'}, {'type': 'PRIMARY', 'title': 'AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trandolapril', 'description': 'Trandolapril 4 mg Tablet (test) dosed in either period'}, {'id': 'OG001', 'title': 'Mavik®', 'description': 'Mavik® 4 mg Tablet (reference) dosed in either period'}], 'classes': [{'categories': [{'measurements': [{'value': '4868.37', 'spread': '2340.05', 'groupId': 'OG000'}, {'value': '4826.71', 'spread': '2022.13', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Least Squares Means', 'ciPctValue': '90', 'paramValue': '100.35', 'ciLowerLimit': '92.08', 'ciUpperLimit': '109.36', 'estimateComment': 'Bioequivalence is established when 90% Confidence Interval falls within 80-125.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over 24 hour period', 'description': 'Bioequivalence based on AUC0-inf', 'unitOfMeasure': 'pg*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from all subjects who completed the study were included in the statistical analysis.', 'anticipatedPostingDate': '2009-07'}, {'type': 'PRIMARY', 'title': 'AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trandolapril', 'description': 'Trandolapril 4 mg Tablet (test) dosed in either period'}, {'id': 'OG001', 'title': 'Mavik®', 'description': 'Mavik® 4 mg Tablet (reference) dosed in either period'}], 'classes': [{'categories': [{'measurements': [{'value': '4609.82', 'spread': '2178.05', 'groupId': 'OG000'}, {'value': '4612.53', 'spread': '1897.96', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Least Squares Means', 'ciPctValue': '90', 'paramValue': '99.17', 'ciLowerLimit': '92.71', 'ciUpperLimit': '106.08', 'estimateComment': 'Bioequivalence is established when 90% Confidence Interval falls within 80-125.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over 24 hour period', 'description': 'Bioequivalence based on AUC0-t', 'unitOfMeasure': 'pg*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data from all subjects who completed the study were included in the statistical analysis.', 'anticipatedPostingDate': '2009-07'}, {'type': 'SECONDARY', 'title': 'Cmax - Trandolaprilat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trandolapril', 'description': 'Trandolapril 4 mg Tablet (test) dosed in either period'}, {'id': 'OG001', 'title': 'Mavik®', 'description': 'Mavik® 4 mg Tablet (reference) dosed in either period'}], 'classes': [{'categories': [{'measurements': [{'value': '6682.74', 'spread': '2005.26', 'groupId': 'OG000'}, {'value': '6526.16', 'spread': '1961.47', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Least Squares Means', 'ciPctValue': '90', 'paramValue': '102.93', 'ciLowerLimit': '99.80', 'ciUpperLimit': '106.15', 'estimateComment': 'Informational Purposes Only', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over 72 hour period', 'description': 'Informational Purposes Only', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2009-06'}, {'type': 'SECONDARY', 'title': 'AUC0-inf - Trandolaprilat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trandolapril', 'description': 'Trandolapril 4 mg Tablet (test) dosed in either period'}, {'id': 'OG001', 'title': 'Mavik®', 'description': 'Mavik® 4 mg Tablet (reference) dosed in either period'}], 'classes': [{'categories': [{'measurements': [{'value': '138305.28', 'spread': '25043.67', 'groupId': 'OG000'}, {'value': '138925.03', 'spread': '29142.49', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Least Squares Means', 'ciPctValue': '90', 'paramValue': '100.24', 'ciLowerLimit': '98.11', 'ciUpperLimit': '102.43', 'estimateComment': 'Informational Purposes Only', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over 72 hour period', 'description': 'Informational Purposes Only', 'unitOfMeasure': 'pg*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2009-07'}, {'type': 'SECONDARY', 'title': 'AUC0-t - Trandolaprilat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trandolapril', 'description': 'Trandolapril 4 mg Tablet (test) dosed in either period'}, {'id': 'OG001', 'title': 'Mavik®', 'description': 'Mavik® 4 mg Tablet (reference) dosed in either period'}], 'classes': [{'categories': [{'measurements': [{'value': '111204.01', 'spread': '18419.42', 'groupId': 'OG000'}, {'value': '111685.36', 'spread': '20122.99', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Least Squares Means', 'ciPctValue': '90', 'paramValue': '100.10', 'ciLowerLimit': '98.12', 'ciUpperLimit': '102.12', 'estimateComment': 'Informational Purposes Only', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.'}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples collected over 72 hour period', 'description': 'Informational Purposes Only', 'unitOfMeasure': 'pg*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'anticipatedPostingDate': '2009-07'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Trandolapril (Test) First', 'description': 'Trandolapril 4 mg Tablet (test) dosed in first period followed by Mavik® 4 mg Tablet (reference) dosed in second period'}, {'id': 'FG001', 'title': 'Mavik® (Reference) First', 'description': 'Mavik® 4 mg Tablet (reference) dosed in first period followed by Trandolapril 4 mg Tablet (test) dosed in second period'}], 'periods': [{'title': 'First Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Second Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Trandolapril (Test) First', 'description': 'Trandolapril 4 mg Tablet (test) dosed in first period followed by Mavik® 4 mg Tablet (reference) dosed in second period'}, {'id': 'BG001', 'title': 'Mavik® (Reference) First', 'description': 'Mavik® 4 mg Tablet (reference) dosed in first period followed by Trandolapril 4 mg Tablet (test) dosed in second period'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-16', 'studyFirstSubmitDate': '2009-02-06', 'resultsFirstSubmitDate': '2009-07-06', 'studyFirstSubmitQcDate': '2009-02-06', 'lastUpdatePostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-07-06', 'studyFirstPostDateStruct': {'date': '2009-02-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax - Maximum Observed Concentration', 'timeFrame': 'Blood samples collected over 24 hour period', 'description': 'Bioequivalence based on Cmax'}, {'measure': 'AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)', 'timeFrame': 'Blood samples collected over 24 hour period', 'description': 'Bioequivalence based on AUC0-inf'}, {'measure': 'AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)', 'timeFrame': 'Blood samples collected over 24 hour period', 'description': 'Bioequivalence based on AUC0-t'}], 'secondaryOutcomes': [{'measure': 'Cmax - Trandolaprilat', 'timeFrame': 'Blood samples collected over 72 hour period', 'description': 'Informational Purposes Only'}, {'measure': 'AUC0-inf - Trandolaprilat', 'timeFrame': 'Blood samples collected over 72 hour period', 'description': 'Informational Purposes Only'}, {'measure': 'AUC0-t - Trandolaprilat', 'timeFrame': 'Blood samples collected over 72 hour period', 'description': 'Informational Purposes Only'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bioequivalence', 'Healthy Subjects'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare the rate and extent of absorption of trandolapril from a test formulation of Trandolapril 4 mg Tablets versus the reference Mavik® 4 mg Tablets under fasting conditions.', 'detailedDescription': 'Criteria for Evaluation: FDA Bioequivalence Criteria\n\nStatistical Methods: FDA bioequivalence statistical methods'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Non-smoking male or female with a minimum age of 18 years (i.e. non-smoker or non-tobacco user for at least 90 days prior to pre-study medical screening).\n* Body Mass Index (BMI = weight/height2) greater than or equal to 19.0 kg.m2 and less than or equal to 30.0 kg/m2.\n* Normal findings in the physical examination, 12-lead ECG and vital signs (blood pressure between 100-140/60-90 mmHg, heart rate between 50-100 beats/min, temperature between 35.8°C and 37.5°C).\n* Negative for drugs of abuse, nicotine, hepatitis B-surface antigen, hepatitis C and HIV, and for female subjects, pregnancy (serum β-CG).\n* No clinical laboratory values outside of the acceptable range as defined by BCR, unless the Principal Investigator decides they are not clinically significant.\n* Female subjects who are surgically sterile for at least six months or post-menopausal for at least one year, or who will avoid pregnancy prior to the study, during the study and up until one month after the end of the study.\n\nExclusion Criteria\n\n* Known history of hypersensitivity to trandolapril (e.g. Mavik®) other ACE inhibitors such as captopril, benazepril, enalapril, lisinopril, ramipril, quinapril, or cilazapril or angiotensin receptor agonists such as losartan, candesartan, eprosartan, irbesartan, telmisartan, or valsartan.\n* Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, liver or kidney disease, unless judged not clinically significant by the Principal Investigator or medical designate.\n* Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs.\n* Any clinically significant illness during the last four weeks prior to entry into this study.\n* Presence of any significant physical or organ abnormality.\n* Any subject with a history of drug abuse.\n* Any history or evidence of psychiatric or psychological disease (including depression) unless deemed not clinically significant by the Principal Investigator, or medical designate.\n* Use of any prescription medication within 14 days preceding entry into this study.\n* Use of over the counter (OTC) medication within seven days preceding entry into this study (except for spermicidal/barrier contraceptive products).\n* Female subjects: use of contraceptives (oral, transdermal, implant, Mirena® IUD) within 30 days prior to drug administration or a depot injection of progestogen drug (e.g. Depo-Provera®) within one year prior to drug administration.\n* Female subjects: presence of pregnancy or lactation.\n* Any subject who has had blood drawn within 56 days preceding this study, taken during the conduct of any clinical study at a facility other than BCR, or within the lockout period specified by a previous study conducted at BCR.\n* Participation in a clinical trial with an investigational drug within 30 days preceding this study.\n* Any subject who has donated blood within 56 days preceding this study.\n* Any subject who has participated as a plasma donor in a plasmapheresis program within seven days preceding this study.\n* Significant or recent history of asthma (after 12 years of age).\n* Any subject with a recent (less than one year) history of alcohol abuse.\n* Known history of frequent headaches or migraines.\n* Known history of hereditary or idiopathic angioedema.\n* Any history of severe allergic reaction (including drugs, food, insect bites, environmental allergens).\n* Intolerance to venipuncture.\n* Any clinically significant surgery within 4 weeks prior to the administration of the study medication.\n* Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoine, glucocorticoids, omeprazole,; examples of inhibitors: antidepressant (SSRI), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to administration of the study medication.\n* Difficulty swallowing study medication.\n* Difficulty fasting or consuming standard meals.'}, 'identificationModule': {'nctId': 'NCT00840632', 'briefTitle': 'Trandolapril 4 mg Tablet Under Fasting Conditions', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Pharmaceuticals USA'}, 'officialTitle': 'A Two-Way Crossover, Open-Label, Single-Dose, Fasting, Bioequivalence Study of Trandolapril 4 mg Tablets Versus Mavik® 4 mg Tablets in Normal Healthy Non-Smoking Male and Female Subjects', 'orgStudyIdInfo': {'id': '2977'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trandolapril', 'description': 'Trandolapril 4 mg Tablet (test) dosed in first period followed by Mavik® 4 mg Tablet (reference) dosed in second period', 'interventionNames': ['Drug: Trandolapril 4 mg Tablets']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mavik®', 'description': 'Mavik® 4 mg Tablet (reference) dosed in first period followed by Trandolapril 4 mg Tablet (test) dosed in second period', 'interventionNames': ['Drug: Mavik® 4 mg Tablets']}], 'interventions': [{'name': 'Trandolapril 4 mg Tablets', 'type': 'DRUG', 'description': '1 x 4 mg, single-dose fasting', 'armGroupLabels': ['Trandolapril']}, {'name': 'Mavik® 4 mg Tablets', 'type': 'DRUG', 'description': '1 x 4 mg, single-dose fasting', 'armGroupLabels': ['Mavik®']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M1L 4S4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Biovail Contract Research', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Paul Y Tam, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Biovail'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Pharmaceuticals USA', 'class': 'INDUSTRY'}}}}