Back to resultsStudy to Evaluate the Bioequivalence of Pfizer Korea Inc. "XELJANZ 5Mg Tablet" in Healthy Volunteers
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
XELJANZ 5Mg Tablet
Chong Kun Dang Tofacitinib Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Healthy subject older than 19 years at the screening
Individuals who had 18 kg/m2 ≤ Body Mass Index(BMI) ≤ 30kg/m2
* BMI = Weight(kg)/ Height(m)2
- 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)
- Individuals who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, ECG, chest X-ray etc.)
- Women who are not pregnant at physical examination
Exclusion Criteria:
- 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
- Individuals who had taken any medication within 10 days prior to the first day of dosing
- Individuals who were deemed to be inappropriate to participate in the study by the investigator
- Individuals who had participated of other clinical study or bioequivalence study within the 3 months prior to the first day of dosing
- 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)
- 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)
- Individuals with hypersensitivity to ingredients used in the investigational product(s)
- Patients with serious infection (e.g., Sepsis) or active infection including localized infection
- Patients with active tuberculosis
- Patients with severe hepatopathy
- Patients with an absolute neutrophil count (ANC) less than 500 cells/mm3
- Patients with an absolute lymphocyte count (ALC) less than 500 cells/mm3
- Patients who have hemoglobin levels less than 8 g/dL
- Women who are pregnant or may be pregnant or lactating
- Patients with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
- Patients with nephropathy (BUN<8 or BUN>20 or Creatinine>1.5)
Sites / Locations
- Bestian Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Reference/Test
Test/Reference
Arm Description
Period 1: XELJANZ 5Mg Tablet 1T Period 2: Chong Kun Dang Tofacitinib Tablet 1T
Period 1: Chong Kun Dang Tofacitinib Tablet 1T Period 2: XELJANZ 5Mg Tablet 1T
Outcomes
Primary Outcome Measures
AUCt of Chong Kun Dang Tofacitinib Tablet and XELJANZ 5Mg Tablet
Area under the Chong Kun Dang Tofacitinib Tablet / XELJANZ 5Mg Tablet concentration in blood-time curve from zero to final
Cmax of Chong Kun Dang Tofacitinib Tablet and XELJANZ 5Mg Tablet
The maximum Chong Kun Dang Tofacitinib Tablet / XELJANZ 5Mg Tablet concentration in blood sampling time t
Secondary Outcome Measures
Full Information
NCT ID
NCT03868072
First Posted
March 6, 2019
Last Updated
January 28, 2020
Sponsor
Chong Kun Dang Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT03868072
Brief Title
Study to Evaluate the Bioequivalence of Pfizer Korea Inc. "XELJANZ 5Mg Tablet" in Healthy Volunteers
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
February 22, 2019 (Actual)
Primary Completion Date
March 29, 2019 (Actual)
Study Completion Date
April 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Reference/Test
Arm Type
Experimental
Arm Description
Period 1: XELJANZ 5Mg Tablet 1T
Period 2: Chong Kun Dang Tofacitinib Tablet 1T
Arm Title
Test/Reference
Arm Type
Experimental
Arm Description
Period 1: Chong Kun Dang Tofacitinib Tablet 1T
Period 2: XELJANZ 5Mg Tablet 1T
Intervention Type
Drug
Intervention Name(s)
XELJANZ 5Mg Tablet
Intervention Description
XELJANZ 5Mg Tablet 1T single oral administration under fasting
Intervention Type
Drug
Intervention Name(s)
Chong Kun Dang Tofacitinib Tablet
Intervention Description
Chong Kun Dang Tofacitinib Tablet 1T single oral administration under fasting
Primary Outcome Measure Information:
Title
AUCt of Chong Kun Dang Tofacitinib Tablet and XELJANZ 5Mg Tablet
Description
Area under the Chong Kun Dang Tofacitinib Tablet / XELJANZ 5Mg Tablet concentration in blood-time curve from zero to final
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
Title
Cmax of Chong Kun Dang Tofacitinib Tablet and XELJANZ 5Mg Tablet
Description
The maximum Chong Kun Dang Tofacitinib Tablet / XELJANZ 5Mg Tablet concentration in blood sampling time t
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy subject older than 19 years at the screening
Individuals who had 18 kg/m2 ≤ Body Mass Index(BMI) ≤ 30kg/m2
* BMI = Weight(kg)/ Height(m)2
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)
Individuals who were deemed to be appropriate as study subjects in accordance with the screening results (laboratory tests, ECG, chest X-ray etc.)
Women who are not pregnant at physical examination
Exclusion Criteria:
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
Individuals who had taken any medication within 10 days prior to the first day of dosing
Individuals who were deemed to be inappropriate to participate in the study by the investigator
Individuals who had participated of other clinical study or bioequivalence study within the 3 months prior to the first day of dosing
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)
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)
Individuals with hypersensitivity to ingredients used in the investigational product(s)
Patients with serious infection (e.g., Sepsis) or active infection including localized infection
Patients with active tuberculosis
Patients with severe hepatopathy
Patients with an absolute neutrophil count (ANC) less than 500 cells/mm3
Patients with an absolute lymphocyte count (ALC) less than 500 cells/mm3
Patients who have hemoglobin levels less than 8 g/dL
Women who are pregnant or may be pregnant or lactating
Patients with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
Patients with nephropathy (BUN<8 or BUN>20 or Creatinine>1.5)
Facility Information:
Facility Name
Bestian Hospital
City
Osong
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Evaluate the Bioequivalence of Pfizer Korea Inc. "XELJANZ 5Mg Tablet" in Healthy Volunteers
We'll reach out to this number within 24 hrs