Bioequivalence Study of Tacrobell Capsule 1mg to Prograf Capsule 1mg

NCT01910077 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2014-07-23

No results posted yet for this study

Summary

The purpose of this study is to demonstrate bioequivalence between tacrobell capsule 1mg and prograf capsule 1mg.

Conditions

  • Immunosuppression

Interventions

DRUG

Tacrobell capsule 1mg

1 capsule, oral, over the period I\&II(crossover)

DRUG

Prograf capsule 1mg

1 capsule, oral, over the period I\&II(crossover)

Sponsors & Collaborators

  • Chong Kun Dang Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • Hyeong Ki Lee, MD, Ph.D · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2013-08-31
Completion
2013-11-30

Countries

  • South Korea

Study Locations

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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 NCT01910077 on ClinicalTrials.gov