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

NCT03868072 | Completed Phase 1

• 1 other identifier: BE118111814 / BN1-18-118
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Reference/Test

EXPERIMENTAL

1. Period 1: XELJANZ 5Mg Tablet 1T 2. Period 2: Chong Kun Dang Tofacitinib Tablet 1T

Drug: XELJANZ 5Mg Tablet; Drug: Chong Kun Dang Tofacitinib Tablet

Test/Reference

EXPERIMENTAL

1. Period 1: Chong Kun Dang Tofacitinib Tablet 1T 2. Period 2: XELJANZ 5Mg Tablet 1T

Drug: XELJANZ 5Mg Tablet; Drug: Chong Kun Dang Tofacitinib Tablet

Interventions

XELJANZ 5Mg Tablet DRUG

XELJANZ 5Mg Tablet 1T single oral administration under fasting

Reference/Test; Test/Reference

Chong Kun Dang Tofacitinib Tablet DRUG

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

Reference/Test; Test/Reference

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Bestian Hospital

Osŏng, South Korea

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tofacitinib; Tablets

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 8, 2019
• Study Start: February 22, 2019
• Primary Completion: March 29, 2019
• Study Completion: April 20, 2019
• Last Updated: January 30, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)