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Bioequivalence Study of Tacrolimus in Healthy Volunteers

NCT04725682 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2023-09-21

Study results available
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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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Tacrolimus

a single dose of 1 mg capsule per period

Sponsors & Collaborators

  • BioPharma Services Inc.

    collaborator INDUSTRY

  • Food and Drug Administration (FDA)

    lead FED

Principal Investigators

  • Artan Markollari, MD · BioPharma Services Inc.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2021-01-05
Primary Completion
2021-05-14
Completion
2021-06-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04725682 on ClinicalTrials.gov