NCT03868072

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	XELJANZ 5Mg Tablet	XELJANZ 5Mg Tablet 1T single oral administration under fasting
DRUG	Chong Kun Dang Tofacitinib Tablet	Chong Kun Dang Tofacitinib Tablet 1T single oral administration under fasting

Timeline

• Start date: 2019-02-22
• Primary completion: 2019-03-29
• Completion: 2019-04-20
• First posted: 2019-03-08
• Last updated: 2020-01-30

Locations

1 site across 1 country: South Korea