NCT04114461

Study to Evaluate HL-TOF Tab. 5 mg Compared With XelJanz Tab. in Healthy Volunteers

An Open-label, Randomized, Single-dose, 2-sequence, 2-period, Crossover Study to Evaluate the Safety and Pharmacokinetics of HL-TOF Tab. 5 mg Compared With Those of XelJanz Tab. in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Hanlim Pharm. Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 60 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety and pharmacokinetics of HL-TOF tab. 5 mg compared with those of XelJanz tab. in healthy volunteers

Detailed description

The purpose of this study is to evaluate the safety and pharmacokinetics of tofacitinib after single oral administration of Xeljanz tab. 5mg as reference drug and HL-TOF tab. 5mg as test drug in healthy voluteers. AUC and Cmax would be evaluated for the pharmacokinetics. Adverse event, Laboratory examination and other examination result would be evaluated for the safety.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	HL-TOF tab. 5mg	HL-TOF
DRUG	Xeljanz tab. 5mg	Xeljanz

Timeline

• Start date: 2019-11-06
• Primary completion: 2019-12-04
• Completion: 2019-12-04
• First posted: 2019-10-03
• Last updated: 2020-05-12

Locations

1 site across 1 country: South Korea