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

• ClinicalTrials.gov Identifier: NCT04114461
• Recruitment Status: Completed
• First Posted: October 3, 2019
• Last Update Posted: May 12, 2020
• Sponsor: Hanlim Pharm. Co., Ltd.
• Information provided by (Responsible Party): Hanlim Pharm. Co., Ltd.

Tracking Information

• First Submitted Date: October 2, 2019
• First Posted Date: October 3, 2019
• Last Update Posted Date: May 12, 2020
• Actual Study Start Date: November 6, 2019
• Actual Primary Completion Date: December 4, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 2, 2019)

• Cmax [ Time Frame: 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 [ Time Frame: 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 2, 2019)

AE [ Time Frame: 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 1

Study Design

Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

2X2

Masking: None (Open Label)
Primary Purpose: Basic Science

• Condition: Healthy Volunteers

Intervention

• Drug: HL-TOF tab. 5mg
  HL-TOF
  Other Name: Tofacitinib freebase
• Drug: Xeljanz tab. 5mg
  Xeljanz
  Other Name: Tofacitinib citrate

Study Arms

• Experimental: HL-TOF tab. 5mg
  Tofacitinib freebase
  Intervention: Drug: HL-TOF tab. 5mg
• Active Comparator: Xeljanz tab. 5mg
  Tofacitinib citrate (5mg as tofacitinib)
  Intervention: Drug: Xeljanz tab. 5mg

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 7, 2020): 33
• Original Estimated Enrollment (submitted: October 2, 2019): 32
• Actual Study Completion Date: December 4, 2019
• Actual Primary Completion Date: December 4, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT04114461
• Other Study ID Numbers: HL-TOF-101
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Hanlim Pharm. Co., Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Hanlim Pharm. Co., Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: JAEWOO KIM; H Plus Yangji Hospital

• PRS Account: Hanlim Pharm. Co., Ltd.
• Verification Date: May 2020