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NCT06337422

Bioequivalence Study of Generic Celecoxib 200 mg Capsules

A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Celecoxib 200 mg Capsules and Reference Product (CELEBREXTM) in Healthy Thai Volunteers Under Fasting Conditions
International Bio service·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Healthy Volunteer
Drug/Device/Intervention
Celecoxib 200 mg capsule
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
International Bio service
Timeline & enrollment
Phase
Phase 1
Start date
Sep 23, 2024
End date
Oct 04, 2024
Enrollment
40 participants
Primary outcome

Bioequivalence based on Cmax period,Bioequivalence based on AUC parameters

Summary

To determine and compare the rate and extent of absorption of a test formulation with that of
 a reference innovator formulation when given as equal labeled dose in healthy subjects under
 fasting conditions

ICD-10 classifications
Healthy person accompanying sick personRoutine general health check-up of armed forcesPersons encountering health services in other circumstancesPersons encountering health services in other circumstancesPerson encountering health services in unspecified circumstances
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06337422
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06337422 through Pure Global AI's free database. This Phase 1 trial is sponsored by International Bio service and is currently Not yet recruiting. The study focuses on Healthy Volunteer. Target enrollment is 40 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.