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

NCT ID: NCT04114461

Last Updated: 2020-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-06
• Study Completion Date: 2019-12-04

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

HL-TOF tab. 5mg

Tofacitinib freebase

Group Type: EXPERIMENTAL

HL-TOF tab. 5mg

Intervention Type: DRUG

HL-TOF

Xeljanz tab. 5mg

Tofacitinib citrate (5mg as tofacitinib)

Group Type: ACTIVE_COMPARATOR

Xeljanz tab. 5mg

Intervention Type: DRUG

Xeljanz

Interventions

HL-TOF tab. 5mg

HL-TOF

Intervention Type: DRUG

Xeljanz tab. 5mg

Xeljanz

Intervention Type: DRUG

Other Intervention Names

Tofacitinib freebase; Tofacitinib citrate

Eligibility Criteria

Inclusion Criteria

• Years 19-60
• No pathological symptoms or findings
• Suitable for the criteria for examination
• 90≤SBP≤139, 60≤DBP≤89
• Body weight≥50kg (Female≥45kg) and 18≤BMI≤30kg/m2
• Contraceptive during the study period
• Volunteer for the study and sign to ICF

Exclusion Criteria

• Subject with medical history which affect on the absorption of drug
• Following condition: Mental illness, Hepatic disorder, Tuberculosis, ANC< 500cells/mm3, ALC<500cells/mm3, Hb<8g/dL
• Subject with hypersensitivity reaction to HL-TOF and Xeljanz
• Subject with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
• Subject who take a vaccination within 30 days
• Subject who take a medication such as barbiturates within 30 days
• Subject who take a medication that affect to the pharmacokinetics of drug within 10 days
• Subject who take alcohol more than 21 cups per week
• Subject who smoke 20 cigarettes per day
• Subject who participate in any clinical investigation within 6 month prior to study medication dosing
• Subject with whole blood donation within 60 days, component blood donation within 14 days, blood donation within 30 days
• Subject with decision of non-participation through investigator's review

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hanlim Pharm. Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

JAEWOO KIM

Role: PRINCIPAL_INVESTIGATOR

H Plus Yangji Hospital

Locations

YANGJI Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

HL-TOF-101

Identifier Type: -

Identifier Source: org_study_id