Overview

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

Status:
Not yet recruiting
Trial end date:
2024-08-24
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
International Bio service
Treatments:
Simvastatin