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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04114461

Enrollment

Registered

2019-10-03

Start date

2019-11-06

Completion date

2019-12-04

Last updated

2020-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

DRUGHL-TOF tab. 5mg

HL-TOF

DRUGXeljanz tab. 5mg

Xeljanz

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention model description

2X2

Eligibility

Sex/Gender

ALL

Age

19 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026