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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04114461
• Other study ID #: HL-TOF-101
• Status: Completed
• Phase: Phase 1
• Start date: November 6, 2019
• Est. completion date: December 4, 2019

Study information

• Verified date: May 2020
• Source: Hanlim Pharm. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 4, 2019
• Est. primary completion date: December 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• HL-TOF tab. 5mg
HL-TOF
• Xeljanz tab. 5mg
Xeljanz

Locations

Country	Name	City	State
Korea, Republic of	YANGJI Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanlim Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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