CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 28 enrolled
Drug / intervention
Epivir ® tablet 150-mg single dose (drug reference) +1 moredrug
Likely dose
Epivir ® tablet 150-mg single dose (drug reference) 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02604004
NCT02604004Phase 1Completed
CompareCT.gov

Bioequivalence Study Between Lamivudine Formulations in the Form of Coated Tablet 150 mg (Test) and EPIVIR of Glaxosmithkline in Healthy Volunteers of Both Genders in Fasting Condition

Universidade Federal de Pernambuco·interventional·Posted Nov 13, 2015·Updated Nov 13, 2015

In Brief

A Phase 1 clinical trial evaluating Epivir ® tablet 150-mg single dose (drug reference) and Lamivudine 150-mg tablet single dose (drug test) for HIV INFECTIONS. Completed, enrolled 28 participants.

Detailed Summary

The objective of this research is to check whether the test drug (lamivudine in the form of coated tablet 150 mg) achieves plasma levels equivalent to those obtained from the EPIVIR in the form of coated tablet 150 mg GlaxoSmithKline administered to 28 volunteers of both genres under fasting condition.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV INFECTIONS
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 13, 2015
Enrollment StartApr 1, 2013
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.6 years ago

Interventions

Epivir ® tablet 150-mg single dose (drug reference)drug

Bioequivalence lamivudine 150 mg tablets fasting condition

Lamivudine 150-mg tablet single dose (drug test)drug

Bioequivalence lamivudine 150 mg tablets fasting condition