NCT06193044

Bioequivalence Study of Amlodipine/Valsartan 10/160 mg Film Coated Tablets

A Single Dose, Randomized, Open-label, Two-treatment, Four-period, Two-sequence, Replicate Crossover Bioequivalence Study of Generic Amlodipine and Valsartan Tablets 10/160 mg and Reference Product (Exforge® 10/160 mg Tablets)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: International Bio service · Network
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Comparative randomized, Single dose, Two-treatment, Four-period, Two-sequence, Replicate Crossover Bioequivalence Study to determine the bioequivalence of Amlodipine / valsartan from Amlodipine/Valsartan 10/160 film coated tablets and Exforge10/160 mg film coated tablets (Novartis Pharma, USA).

Detailed description

The primary objective of this bioequivalence study is to assess and compare the rate and extent of absorption of a test formulation against a reference formulation, with an additional focus on evaluating the safety profiles of both formulations. This study aims to provide critical insights into the bioequivalence of the two formulations, shedding light on their pharmacokinetic parameters and overall safety in the context of therapeutic efficacy. Study Design: The study adopts an Open-label, Two-treatment, Four-period, Two-sequence, Replicate Crossover Bioequivalence Study design to ensure robustness and reliability in the evaluation of bioequivalence. The Replicate Crossover design minimizes the impact of inter-individual variability, allowing for a more accurate assessment of the formulations' performance. Participant Selection: A total of 48 healthy Thai volunteers will be recruited to participate in the study. The inclusion criteria involve individuals who meet specific health standards and are willing to comply with the study requirements. The emphasis on recruiting healthy volunteers aims to establish a baseline for comparison, ensuring that any observed differences in absorption and safety can be attributed to the formulations under investigation. Study Conditions: The study will be conducted under fasting conditions to isolate the impact of the formulations on absorption without interference from food-related variables. Fasting conditions provide a controlled environment to evaluate the formulations' performance and allow for a more accurate determination of bioequivalence.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	Amlodipine/Valsartan	Amlodipine 10 mg \&valsartan 160 mg
DRUG	Amlodipine 10 mg &valsartan 160 mg (Exforge)	Amlodipine 10 mg \&valsartan 160 mg

Timeline

• Start date: 2024-05-07
• Primary completion: 2024-07-09
• Completion: 2024-07-12
• First posted: 2024-01-05
• Last updated: 2024-01-09