Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-02-25 @ 4:56 PM
Study NCT ID:
NCT03777605
Status:
UNKNOWN
Last Update Posted:
2018-12-19
First Post:
2018-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Absorption and Pharmacokinetics of Nitroglycerin to a New Formulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000787', 'term': 'Angina Pectoris'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005996', 'term': 'Nitroglycerin'}], 'ancestors': [{'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'All tablets are processed, marked and coded by a pharmacist,'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A randomized, cross over design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-12-23', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2020-12-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-17', 'studyFirstSubmitDate': '2018-12-03', 'studyFirstSubmitQcDate': '2018-12-13', 'lastUpdatePostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak Plasma Concentration of Nitroglycerine as a tablet or in the form of rapidly degradable capsule "NTG1523" in young healthy controls', 'timeFrame': 'From 2 weeks up til 5 weeks', 'description': 'Peak Plasma Concentration (Cmax)(ng(ml) of nitroglycerine'}], 'secondaryOutcomes': [{'measure': 'Blood pressure in response to Nitroglycerine', 'timeFrame': 'From 2 weeks up til 5 weeks', 'description': 'Blood pressure (mmHg)'}, {'measure': 'Puls rate in response to Nitroglycerine', 'timeFrame': 'From 2 weeks up til 5 weeks', 'description': 'puls rate (beat/min)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Angina Pectoris']}, 'referencesModule': {'references': [{'pmid': '2111749', 'type': 'BACKGROUND', 'citation': 'Nakashima E, Rigod JF, Lin ET, Benet LZ. Pharmacokinetics of nitroglycerin and its dinitrate metabolites over a thirtyfold range of oral doses. Clin Pharmacol Ther. 1990 May;47(5):592-8. doi: 10.1038/clpt.1990.80.'}, {'pmid': '3085698', 'type': 'RESULT', 'citation': 'McAllister A, Mosberg H, Settlage JA, Steiner JA. Plasma levels of nitroglycerin generated by three nitroglycerin patch preparations, Nitradisc, Transiderm-Nitro and Nitro-Dur and one ointment formulation, Nitrobid. Br J Clin Pharmacol. 1986 Apr;21(4):365-9. doi: 10.1111/j.1365-2125.1986.tb05208.x.'}]}, 'descriptionModule': {'briefSummary': 'The study evaluate the absorption rate of different sublingual formulation of nitroglycerine (NTG) either in the form of available tablets or a new rapid absorbable gelation capsule formulation "NTG1523" by determining T-max and area under the response curve of nitoglycerine in blood concentration as well as from clinical effects after intake. Data is entered on data sheet in anonymous form and processed. The results are presented in anonymous form by publication and lecture. Experts are given the supplement: "The applicant\'s rights in a biomedical research project', 'detailedDescription': 'Ten healthy young volunteers are recruited,, and the experiments begin at 07:45 after an overneight fast. BMI and blod pressure are recorded and a catheter is inserted in an anticubical vein for blood samples.\n\nAt 08.00 a sublingual tablet (Takeda, nitroglycerin 0.4 milligrams) tablet or a "NTG1523" capsule with 0.4 milligrams of nitroglycerine is placed under the tongue in random order. Subsequently, blood samples are taken every minute for 10 minutes, then every 10 minutes the following two hours. In addition, blood pressure and puls rate are measured every second minute the first ten minutes, and then every 10 minutes.Side effects and time to the participants registrate any effect of the drugs are assessed in a prefabricated scheme.\n\nThe disadvantages associated with the experiment are sought monitored by adverse event registration which ends at the end of the trial. The trial day lasts 2 hours in which blood samples are taken as described above, and blood pressure and records are stored .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '28 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal healthy volunteers\n* Must be able to swallow tablets\n\nExclusion Criteria:\n\n* Insulin dependent diabetes\n* Thyroid disease\n* any medial treatment'}, 'identificationModule': {'nctId': 'NCT03777605', 'briefTitle': 'Absorption and Pharmacokinetics of Nitroglycerin to a New Formulation', 'organization': {'class': 'OTHER', 'fullName': 'Kolding Sygehus'}, 'officialTitle': 'Absorption and Pharmacokinetics of Nitroglycerin as a Tablet or in the Form of Rapidly Degradable Capsule in Young Healthy', 'orgStudyIdInfo': {'id': 'Nitroglycerine1523 (NTG1523)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '"NTG1523", rapid absorbable capsule', 'description': 'Nitroglycerine 0.4 milligram taken as ordinary tablets or "NTG1523" rapid absorbable capsule once in the morning, and subsequently blood samples and observations for 2 hours are performed', 'interventionNames': ['Drug: Nitroglycerin 0.4 MG']}], 'interventions': [{'name': 'Nitroglycerin 0.4 MG', 'type': 'DRUG', 'otherNames': ['"NTG1523"'], 'description': 'The study evaluate absorption rate of nitroglycerine 0.4 milligrams as tablets or a quickly absorbable capsuel "NTG1523" determined by T-max and area under the response curve in the blood of NTG as well as from clinical effects.\n\nData is entered on data sheet in anonymous form and processed. The results are presented in anonymous form by publication and lecture. Experts are given the supplement: "The applicant\'s rights in a biomedical research project', 'armGroupLabels': ['"NTG1523", rapid absorbable capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6000', 'city': 'Kolding', 'country': 'Denmark', 'facility': 'Kolfding Sygehus, SLB', 'geoPoint': {'lat': 55.4904, 'lon': 9.47216}}], 'centralContacts': [{'name': 'ole W Rasmussen, M.D., Dr.Sci', 'role': 'CONTACT', 'email': 'olew.rasmussen@dadlnet.dk', 'phone': '+4550506930'}, {'name': 'Poul H Madsen, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'Poul.Henning.Madsen@rsyd.dk', 'phone': '+45 76362000'}], 'overallOfficials': [{'name': 'ole W Rasmussen, M.D. Dr.Sci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Dept.,Kolding Hospital, SLB, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kolding Sygehus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical professor', 'investigatorFullName': 'Ole Winther Rasmussen', 'investigatorAffiliation': 'Kolding Sygehus'}}}}