Study to Evaluate the Bioequivalence of Pfizer Korea Inc. "XELJANZ 5Mg Tablet" in Healthy Volunteers

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03868072
• Other study ID #: BE118111814 / BN1-18-118
• Status: Completed
• Phase: Phase 1
• Start date: February 22, 2019
• Est. completion date: April 20, 2019

Study information

• Verified date: January 2020
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 20, 2019
• Est. primary completion date: March 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• XELJANZ 5Mg Tablet
XELJANZ 5Mg Tablet 1T single oral administration under fasting
• Chong Kun Dang Tofacitinib Tablet
Chong Kun Dang Tofacitinib Tablet 1T single oral administration under fasting

Locations

Country	Name	City	State
Korea, Republic of	Bestian Hospital	Osong

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Primary	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	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