Bioequivalence Study of Two Formulations of Telmisartan 80 mg Tablets in Healthy Adult Volunteers Under Fasting State

Bioequivalence Clinical Trial

Official title: Single Dose, Full Replicate, Crossover Comparative Bioavailability Study of Telmisartan 80 mg Tablets in Healthy Male and Female Volunteers / Fasting State

Status Completed

Clinical Trial Summary

This single center, randomized, single dose, full replicate, crossover comparative laboratory-blinded study will be conducted in healthy male and female volunteers in order to determine the bioequivalence of two different formulations of telmisartan 80 mg tablets after oral administration under fasting conditions.

Clinical Trial Description

The study is characterized by single center, randomized, single dose, laboratory-blinded, 4-period, 2-sequence, full replicate crossover design.The objective is to determine the bioequivalence of two different formulations of telmisartan after a single oral dose administration under fasting conditions. The test product is Telmisartan 80 mg tablets manufactured by Pharmtechnology LLC, Belarus. The reference product is Micardis 80 mg tablets manufactured by Boehringer Ingelheim Ellas AE, Greece. The primary study endpoints are the pharmacokinetic parameters Cmax and AUC0-T of telmisartan.

Eligible 26 healthy adult subjects will be randomized to the one of two predetermined sequences: ABAB or BABA where A = the test product, B = the reference product. Clinical part of the study will include 4 periods; in each of them a single 80 mg dose of telmisartan will be administered orally with approximately 240 mL of water, in the morning, following a 10-hour overnight fast. Wash-out period between treatment administrations will last at least 14 calendar days.

Subjects will be confined to the clinical site from at least 10 hours prior to each drug administration until 24 hours following each drug administration. Subjects will return to the clinical site for the remaining blood samples.

In each study period, 21 blood samples will be collected for pharmacokinetic assessments. The first blood sample will be collected prior to drug administration while the others will be collected up to 72 hours after drug administration (0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 postdose) .

Total study duration: up to 74 days (including screening).

Telmisartan plasma concentrations will be measured by a validated bioanalytical method.

Statistical analysis of pharmacokinetic parameters will be based on an ANOVA model. Two-sided 90% confidence interval of the ratio of geometric LSmeans will be obtained from the ln-transformed pharmacokinetic parameters.

Statistical inference of telmisartan will be based on a bioequivalence approach using the following standards:

• average bioequivalence (the ratio of geometric LSmeans with corresponding 90% confidence interval calculated from the exponential of the difference between the test and the reference product for the ln-transformed parameters Cmax and AUC0-T should all be within the 80.00 to 125.00% bioequivalence range);

• scaled-average-bioequivalence (in the event that the Cmax reference-to-reference within-subject CV is greater than 30%, that its test-to-reference geometric LSmeans ratio is within the bioequivalence range of 80.00 125.00% and the average bioequivalence criteria are not met, a scaling approach to the bioequivalence assessment will be used). ;

Related Conditions & MeSH terms

• Bioequivalence

• NCT number: NCT03705533
• Study type: Interventional
• Source: Pharmtechnology LLC
• Status: Completed
• Phase: Phase 1
• Start date: September 7, 2018
• Completion date: December 19, 2018