Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Evaluate the Bioequivalence of Pfizer Korea Inc. "XELJANZ 5Mg Tablet" 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03868072
Recruitment Status : Recruiting
First Posted : March 8, 2019
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Brief Summary:
This study is an open-label, randomized, fasted, single dose, crossover study to evaluate the bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tofacitinib Tablet" and Pfizer Korea Inc. "XELJANZ 5Mg Tablet" in healthy volunteers

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: XELJANZ 5Mg Tablet Drug: Chong Kun Dang Tofacitinib Tablet Phase 1

Detailed Description:

To healthy subjects of forty (40), following treatments are administered dosing in each period and wash-out period is a minimum of 1 week.

Reference drug: XELJANZ 5Mg Tablet / Test drug: Chong Kun Dang Tofacitinib Tablet Pharmacokinetic blood samples are collected up to 12hrs. The pharmacokinetic characteristics and safety are assessed.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Fasted, Single Dose, Crossover Study to Evaluate the Bioequivalence of Chong Kun Dang Pharmaceutical "Chong Kun Dang Tofacitinib Tablet" and Pfizer Korea Inc. "XELJANZ 5Mg Tablet" in Healthy Volunteers
Actual Study Start Date : February 22, 2019
Estimated Primary Completion Date : March 29, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Reference/Test
  1. Period 1: XELJANZ 5Mg Tablet 1T
  2. Period 2: Chong Kun Dang Tofacitinib Tablet 1T
Drug: XELJANZ 5Mg Tablet
XELJANZ 5Mg Tablet 1T single oral administration under fasting

Drug: Chong Kun Dang Tofacitinib Tablet
Chong Kun Dang Tofacitinib Tablet 1T single oral administration under fasting

Experimental: Test/Reference
  1. Period 1: Chong Kun Dang Tofacitinib Tablet 1T
  2. Period 2: XELJANZ 5Mg Tablet 1T
Drug: XELJANZ 5Mg Tablet
XELJANZ 5Mg Tablet 1T single oral administration under fasting

Drug: Chong Kun Dang Tofacitinib Tablet
Chong Kun Dang Tofacitinib Tablet 1T single oral administration under fasting




Primary Outcome Measures :
  1. AUCt of Chong Kun Dang Tofacitinib Tablet and XELJANZ 5Mg Tablet [ Time Frame: Pre-dose (0 hour), post-dose 0.083, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours ]
    Area under the Chong Kun Dang Tofacitinib Tablet / XELJANZ 5Mg Tablet concentration in blood-time curve from zero to final

  2. Cmax of Chong Kun Dang Tofacitinib Tablet and XELJANZ 5Mg Tablet [ Time Frame: Pre-dose (0 hour), post-dose 0.083, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12 hours ]
    The maximum Chong Kun Dang Tofacitinib Tablet / XELJANZ 5Mg Tablet concentration in blood sampling time t



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy subject older than 19 years at the screening
  2. Individuals who had 18 kg/m2 ≤ Body Mass Index(BMI) ≤ 30kg/m2

    * BMI = Weight(kg)/ Height(m)2

  3. Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination(if necessary, EEG, ECG, chest X-ray, endoscope or upper gastrointestinal radiography)
  4. Individuals who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, ECG, chest X-ray etc.)
  5. Women who are not pregnant at physical examination

Exclusion Criteria:

  1. Individuals who had enrolled to barbiturate's drugs by induction and inhibition of drug-metabolizing enzymes of drugs, such as drugs or excessive drinking within the 1 month
  2. Individuals who had taken any medication within 10 days prior to the first day of dosing
  3. Individuals who were deemed to be inappropriate to participate in the study by the investigator
  4. Individuals who had participated of other clinical study or bioequivalence study within the 3 months prior to the first day of dosing
  5. Individuals who donated whole blood within the 2 months, or blood components within 2 weeks prior to the first dose of the investigational product(s)
  6. Individuals who do not agree to the approved methods of double contraception and using spermicide for up to 7 days (only, 4 weeks for women who may be pregnant) after investigational product(s) administration (Double contraception: two or more of the use of condoms, intrauterine contraception, diaphragm, cervical cap, or a sexual partner who had been medically diagnosed infertility)
  7. Individuals with hypersensitivity to ingredients used in the investigational product(s)
  8. Patients with serious infection (e.g., Sepsis) or active infection including localized infection
  9. Patients with active tuberculosis
  10. Patients with severe hepatopathy
  11. Patients with an absolute neutrophil count (ANC) less than 500 cells/mm3
  12. Patients with an absolute lymphocyte count (ALC) less than 500 cells/mm3
  13. Patients who have hemoglobin levels less than 8 g/dL
  14. Women who are pregnant or may be pregnant or lactating
  15. Patients with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
  16. Patients with nephropathy (BUN<8 or BUN>20 or Creatinine>1.5)

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): NCT03868072


Contacts
Layout table for location contacts
Contact: Yu-Jung Cha, Manager +82-43-904-8840 goldenlime0128@bestian.kr
Contact: Min-Ki Kim tigerkmk1@bestian.kr

Locations
Layout table for location information
Korea, Republic of
Bestian Hospital Recruiting
Osong, Korea, Republic of
Contact: Yu-Jung Cha, Professor         
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical

Layout table for additonal information
Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT03868072     History of Changes
Other Study ID Numbers: BE118111814 / BN1-18-118
First Posted: March 8, 2019    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action