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

Hanlim Pharm

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Xeljanz tab. 5mg; Drug: HL-TOF tab. 5mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04114461

HL-TOF-101

Details and patient eligibility

About

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

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 19 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

HL-TOF tab. 5mg

Experimental group

Description:

Tofacitinib freebase

Treatment:

Drug: HL-TOF tab. 5mg

Xeljanz tab. 5mg

Active Comparator group

Description:

Tofacitinib citrate (5mg as tofacitinib)

Treatment:

Drug: Xeljanz tab. 5mg