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

Sponsor
Chong Kun Dang Pharmaceutical
Study ID
NCT03868072
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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

Key Dates

Start date
Feb 22, 2019
Status verified
Jan 2020
Primary completion
Mar 29, 2019
Completion
Apr 20, 2019

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Reference/Test
    1. Period 1: XELJANZ 5Mg Tablet 1T 2. Period 2: Chong Kun Dang Tofacitinib Tablet 1T
  • Experimental: Test/Reference
    1. Period 1: Chong Kun Dang Tofacitinib Tablet 1T 2. Period 2: XELJANZ 5Mg Tablet 1T

Primary Outcome Measure

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 ]

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