Study to Evaluate HL-TOF Tab. 5 mg Compared With XelJanz Tab. in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Drug: HL-TOF tab. 5mg
- Registration Number
- NCT04114461
- Lead Sponsor
- Hanlim Pharm. Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description HL-TOF tab. 5mg HL-TOF tab. 5mg Tofacitinib freebase Xeljanz tab. 5mg Xeljanz tab. 5mg Tofacitinib citrate (5mg as tofacitinib)
- Primary Outcome Measures
Name Time Method Cmax 0 hour, 0.17 hour, 0.34 hour, 0.5 hour, 0.67 hour, 0.83 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 9 hour, 12 hour Maximum concentration
AUC 0 hour, 0.17 hour, 0.34 hour, 0.5 hour, 0.67 hour, 0.83 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 9 hour, 12 hour Area under curve
- Secondary Outcome Measures
Name Time Method AE 0 hour, 0.17 hour, 0.34 hour, 0.5 hour, 0.67 hour, 0.83 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 9 hour, 12 hour Number of participants with adverse events
Trial Locations
- Locations (1)
YANGJI Hospital
🇰🇷Seoul, Korea, Republic of