CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 67 enrolled
Drug / intervention
Tacrolimusdrug
Likely dose
Tacrolimus 1 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/NCT04725682
NCT04725682Phase 1Completed
CompareCT.gov

A Single Dose, Open-Label, Randomized, Four-Way Crossover, Fully Replicate, Bioequivalence Study of Generic Tacrolimus and Prograf® Capsules in Healthy Volunteers Under Fasting Conditions

Food and Drug Administration (FDA)·interventional·Posted Jan 27, 2021·Updated Sep 21, 2023

In Brief

A Phase 1 clinical trial evaluating Tacrolimus for Healthy Volunteers. Completed, enrolled 67 participants across 1 site.

Detailed Summary

This is an in-vivo study to investigate the bioequivalence of generic tacrolimus and its reference listed drug (RLD). The objective of this study is to investigate the bioequivalence of generic Tacrolimus and RLD in healthy male and non-pregnant, non-lactating female volunteers under fasting conditions. The outcome of this study will help further understanding about pharmacokinetic (PK) performance of tacrolimus in a healthy volunteer population and improve review standards for bioequivalence of narrow therapeutic index (NTI) drugs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesUnited States
CollaboratorsBioPharma Services Inc.

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedJan 27, 2021
Enrollment StartJan 5, 2021
Primary CompletionMay 14, 2021
Study CompletionJun 17, 2021
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 5.4 years ago

Interventions

Tacrolimusdrug

a single dose of 1 mg capsule per period