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

NCT ID: NCT03868072

Last Updated: 2020-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-22
• Study Completion Date: 2019-04-20

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Reference/Test

1. Period 1: XELJANZ 5Mg Tablet 1T

2. Period 2: Chong Kun Dang Tofacitinib Tablet 1T

Group Type: EXPERIMENTAL

XELJANZ 5Mg Tablet

Intervention Type: DRUG

XELJANZ 5Mg Tablet 1T single oral administration under fasting

Chong Kun Dang Tofacitinib Tablet

Intervention Type: DRUG

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

Test/Reference

1. Period 1: Chong Kun Dang Tofacitinib Tablet 1T

2. Period 2: XELJANZ 5Mg Tablet 1T

Group Type: EXPERIMENTAL

XELJANZ 5Mg Tablet

Intervention Type: DRUG

XELJANZ 5Mg Tablet 1T single oral administration under fasting

Chong Kun Dang Tofacitinib Tablet

Intervention Type: DRUG

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

Interventions

XELJANZ 5Mg Tablet

XELJANZ 5Mg Tablet 1T single oral administration under fasting

Intervention Type: DRUG

Chong Kun Dang Tofacitinib Tablet

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

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bestian Hospital

Osŏng, , South Korea

Countries

South Korea

Other Identifiers

BE118111814 / BN1-18-118

Identifier Type: -

Identifier Source: org_study_id