Clinical trial NCT04114461: Study to Evaluate HL-TOF Tab. 5 mg Compared With XelJanz Tab. in Healthy Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Hanlim Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-10-03
Enrollment: 33
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 2X2
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Cmax
timeFrame: 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
measure: AUC
timeFrame: 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 outcomes:
measure: AE
timeFrame: 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
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: YANGJI Hospital
Study officials:
affiliation: H Plus Yangji Hospital
name: JAEWOO KIM
role: PRINCIPAL_INVESTIGATOR
References: