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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: HL-TOF tab. 5mg
* Drug: Xeljanz tab. 5mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 2X2
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HL-TOF tab. 5mg<br>Tofacitinib freebase | Drug: HL-TOF tab. 5mg<br>* HL-TOF<br>* Other names: Tofacitinib freebase;|
| Active Comparator: Xeljanz tab. 5mg<br>Tofacitinib citrate (5mg as tofacitinib) | Drug: Xeljanz tab. 5mg<br>* Xeljanz<br>* Other names: Tofacitinib citrate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum concentration | 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 | 
| AUC | Area under curve | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AE | Number of participants with adverse events | 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 |