- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03868072
Study to Evaluate the Bioequivalence of Pfizer Korea Inc. "XELJANZ 5Mg Tablet" in Healthy Volunteers
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Osong, Korea, Republic of
- Bestian Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Reference/Test
|
XELJANZ 5Mg Tablet 1T single oral administration under fasting
Chong Kun Dang Tofacitinib Tablet 1T single oral administration under fasting
|
Experimental: Test/Reference
|
XELJANZ 5Mg Tablet 1T single oral administration under fasting
Chong Kun Dang Tofacitinib Tablet 1T single oral administration under fasting
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
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
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BE118111814 / BN1-18-118
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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