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Study to Evaluate the Bioequivalence of Pfizer Korea Inc. "XELJANZ 5Mg Tablet" in Healthy Volunteers

Rheumatoid Arthritis Clinical Trial

Official title:
An Open-label, Randomized, Fasted, Single Dose, Crossover Study to Evaluate the Bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tofacitinib Tablet" and Pfizer Korea Inc. "XELJANZ 5Mg Tablet" in Healthy Volunteers

Clinical Trial Summary

This study is an open-label, randomized, fasted, single dose, crossover study to evaluate the bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tofacitinib Tablet" and Pfizer Korea Inc. "XELJANZ 5Mg Tablet" in healthy volunteers

Clinical Trial Description

To healthy subjects of forty (40), following treatments are administered dosing in each period and wash-out period is a minimum of 1 week.

Reference drug: XELJANZ 5Mg Tablet / Test drug: Chong Kun Dang Tofacitinib Tablet Pharmacokinetic blood samples are collected up to 12hrs. The pharmacokinetic characteristics and safety are assessed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03868072
Study type Interventional
Source Chong Kun Dang Pharmaceutical
Contact
Status Completed
Phase Phase 1
Start date February 22, 2019
Completion date April 20, 2019
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