Status:
COMPLETED
Study to Evaluate HL-TOF Tab. 5 mg Compared With XelJanz Tab. in Healthy Volunteers
Lead Sponsor:
Hanlim Pharm. Co., Ltd.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
19-60 years
Phase:
PHASE1
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 healt...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 4 2019
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04114461
Start Date
November 6 2019
End Date
December 4 2019
Last Update
May 12 2020
Active Locations (1)
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1
YANGJI Hospital
Seoul, South Korea