NCT03858725

Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-374 5 mg in Healthy Volunteers

A Randomized, Open-label, Fasted, Single Dose, Crossover Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-374 5 mg in Healthy Volunteer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 19 Years – 54 Years
• Healthy volunteers: Accepted

Summary

This study is a randomized, open-label, fasted, single dose, crossover study to evaluate the pharmacokinetic profiles and safety of CKD-374 5 mg in healthy volunteers.

Detailed description

To healthy subjects of thirty-six (36), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days. Reference drug: D569 Tab. / Test drug: CKD-374 5mg Tab. Pharmacokinetic blood samples are collected up to 12hrs. The pharmacokinetic characteristics and safety are assessed

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	D569 Tab.	D569 Tab. 1T single oral administration under fasting condition
DRUG	CKD-374 5mg Tab.	CKD-374(Tofacitinib) 5mg Tab. 1T single oral administration under fasting condition

Timeline

• Start date: 2019-02-26
• Primary completion: 2019-04-05
• Completion: 2019-05-08
• First posted: 2019-03-01
• Last updated: 2020-01-30

Locations

1 site across 1 country: South Korea