MedTrace Logo

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

NCT03868072 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-01-30

No results posted yet for this study

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

Interventions

DRUG

XELJANZ 5Mg Tablet

XELJANZ 5Mg Tablet 1T single oral administration under fasting

DRUG

Chong Kun Dang Tofacitinib Tablet

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

Sponsors & Collaborators

  • Chong Kun Dang Pharmaceutical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-22
Primary Completion
2019-03-29
Completion
2019-04-20

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03868072 on ClinicalTrials.gov