Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-01-02 @ 3:01 AM
Study NCT ID:
NCT03898193
Status:
COMPLETED
Last Update Posted:
2019-06-06
First Post:
2019-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Montelukast, 5 mg Chewable Tablets (Pharmtechnology LLC, Belarus), and Singulair®, 5 mg Chewable Tablets (Merck Sharp & Dohme B.V., the Netherlands), in Healthy Volunteers Under Fasting Conditions
Sponsor:
Pharmtechnology LLC
Organization:
Study Overview
Official Title:
Single-Dose Open-label Randomized Crossover, in Two Periods and in Two Sequences, Single-Center Comparative Bioequivalence Study of Montelukast, 5 mg Chewable Tablets (Pharmtechnology LLC, Republic of Belarus), and Singulair®, 5 mg Chewable Tablets (Merck Sharp & Dohme B.V., the Netherlands), in Healthy Volunteers Under Fasting Conditions
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label, randomized, single-center, single-dose, crossover, in two periods and in two sequences comparative study, where each participant is randomly assigned to the reference or the test formulation in each period of the study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent.
Detailed Description:
The objective of this study is to establish if two formulations of montelukast are bioequivalent. Also monitoring, registration and evaluation of adverse events will be performed.
The test formulation is Montelukast, 5 mg сhewable tablets (Pharmtechnology LLC, Belarus). The reference formulation is Singulair®, 5 mg сhewable tablets (Merck Sharp \& Dohme B.V., the Netherlands). 34 healthy adult volunteers of both genders, with age ranging from 18 to 45 years old, will be divided into two cohorts with equal number of participants (17). Each participant in a cohort will receive single tablet (5 mg of montelukast) of the test or the reference product with 200 ml of water after an overnight fast of at least 10 hours, according to the pre-defined randomization list, i. e. 17 participants in each cohort will receive the test product and 17 participants in each cohort will receive the reference product in each of two periods of the study. Participants will fast 4 hours after administration of the study drugs during each study period. Standardized meals will be provided in each study period. Water will not be accessible to the participants 1 hour prior to administration of the study drugs and 2 hours after administration of the study drugs in each period. In each period blood samples will be collected withing 30 minutes before dosing and 0.5, 1.00, 1.5, 1.75, 2.00, 2.25, 2.5, 2.75, 3.00, 3.25, 3.5, 4.00, 4.5, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00 hours after dosing (total number: 20). The washout period will be 7 days.
At the bio-analytical stage, a validated High Performance Liquid Chromatography with Tandem Mass Spectrometry detection (HPLC/MS) method will be used to determine plasma concentrations of montelukast. At all stages of working with biological samples measures to protect montelukast from daylight exposure should be provided.
ANOVA will be performed on log transformed pharmacokinetic parameters Cmax, Area Under the pharmacokinetic Curve from the beginning of the study to the time of the last measured concentration (AUC0-t) and 90% confidence interval will be constructed for the ratio of geometric means of the test and the reference products, obtained from the log-transformed data. Bioequivalence will be concluded if the ratio estimate as well as its 90% confidence interval for montelukast falls within the acceptable range of 80.00% to 125.00% for Cmax and AUC0-t
The test formulation is Montelukast, 5 mg сhewable tablets (Pharmtechnology LLC, Belarus). The reference formulation is Singulair®, 5 mg сhewable tablets (Merck Sharp \& Dohme B.V., the Netherlands). 34 healthy adult volunteers of both genders, with age ranging from 18 to 45 years old, will be divided into two cohorts with equal number of participants (17). Each participant in a cohort will receive single tablet (5 mg of montelukast) of the test or the reference product with 200 ml of water after an overnight fast of at least 10 hours, according to the pre-defined randomization list, i. e. 17 participants in each cohort will receive the test product and 17 participants in each cohort will receive the reference product in each of two periods of the study. Participants will fast 4 hours after administration of the study drugs during each study period. Standardized meals will be provided in each study period. Water will not be accessible to the participants 1 hour prior to administration of the study drugs and 2 hours after administration of the study drugs in each period. In each period blood samples will be collected withing 30 minutes before dosing and 0.5, 1.00, 1.5, 1.75, 2.00, 2.25, 2.5, 2.75, 3.00, 3.25, 3.5, 4.00, 4.5, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00 hours after dosing (total number: 20). The washout period will be 7 days.
At the bio-analytical stage, a validated High Performance Liquid Chromatography with Tandem Mass Spectrometry detection (HPLC/MS) method will be used to determine plasma concentrations of montelukast. At all stages of working with biological samples measures to protect montelukast from daylight exposure should be provided.
ANOVA will be performed on log transformed pharmacokinetic parameters Cmax, Area Under the pharmacokinetic Curve from the beginning of the study to the time of the last measured concentration (AUC0-t) and 90% confidence interval will be constructed for the ratio of geometric means of the test and the reference products, obtained from the log-transformed data. Bioequivalence will be concluded if the ratio estimate as well as its 90% confidence interval for montelukast falls within the acceptable range of 80.00% to 125.00% for Cmax and AUC0-t
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: