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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: HL-TOF tab. 5mg; Drug: Xeljanz tab. 5mg

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Yangji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hanlim Pharm. Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2019
• Primary Completion (Actual): December 4, 2019
• Study Completion (Actual): December 4, 2019

Study Registration Dates

• First Submitted: October 2, 2019
• First Submitted That Met QC Criteria: October 2, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Actual): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 10, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Tofacitinib
• Other Study ID Numbers: HL-TOF-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No