NCT06178640

Bioequivalence Study of Simvastatin 40 mg Film-coated Tablets in Healthy Thai Volunteers

A Single Dose, Randomized, Open-label, Replicated Crossover Bioequivalence Study of Generic Simvastatin 40 mg Film-coated Tablets and Reference Product (ZOCOR®) in Healthy Thai Volunteers Under Fasting Conditions

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: International Bio service · Network
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The goal of this bioequivalence study is to determine and compare the rate and extent of absorption and to evaluate safety of test and reference formulations. Study Design: An open label, randomized, two-treatment, four-period, two-sequence replicate crossover bioequivalence study in 46 healthy Thai volunteers under fasting conditions with at least 7 days washout period.

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, randomized, two-treatment, four-period, two-sequence replicate crossover design to ensure robustness and reliability in the evaluation of bioequivalence. The crossover design minimizes the impact of inter-individual variability, allowing for a more accurate assessment of the formulations' performance. Participant Selection: A total of 46 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	Simvastatin 40 mg film-coated tablet	Simvastatin 40 mg film-coated tablet
DRUG	Zocor 40 mg film-coated tablet	Zocor 40 mg film-coated tablet (Simvastatin 40 mg film-coated tablet: Reference Product)

Timeline

• Start date: 2024-08-13
• Primary completion: 2024-08-17
• Completion: 2024-08-24
• First posted: 2023-12-21
• Last updated: 2024-03-07