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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04114461
Recruitment Status : Completed
First Posted : October 3, 2019
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Hanlim Pharm. Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: HL-TOF tab. 5mg Drug: Xeljanz tab. 5mg Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 2X2
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : November 6, 2019
Actual Primary Completion Date : December 4, 2019
Actual Study Completion Date : December 4, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: HL-TOF tab. 5mg
Tofacitinib freebase
 Drug: HL-TOF tab. 5mg
HL-TOF
Other Name: Tofacitinib freebase
Active Comparator: Xeljanz tab. 5mg
Tofacitinib citrate (5mg as tofacitinib)
 Drug: Xeljanz tab. 5mg
Xeljanz
Other Name: Tofacitinib citrate


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04114461


Locations
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Korea, Republic of
YANGJI Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanlim Pharm. Co., Ltd.
Investigators
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Principal Investigator: JAEWOO KIM H Plus Yangji Hospital
More Information
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Responsible Party: Hanlim Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT04114461    
Other Study ID Numbers: HL-TOF-101
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tofacitinib
Molecular Mechanisms of Pharmacological Action
Janus Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors