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

NCT06178640 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-03-07

No results posted yet for this study

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.

Conditions

  • Healthy Volunteer

Interventions

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)

Sponsors & Collaborators

  • International Bio service

    lead NETWORK

Principal Investigators

  • Uthai Suvanakoot, Ph.D.Pharm · International Bio service

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-13
Primary Completion
2024-08-17
Completion
2024-08-24

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06178640 on ClinicalTrials.gov