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Bioequivalence Study of Generic Celecoxib 200 mg Capsules - Trial NCT06337422

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.

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NCT06337422
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06337422
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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

Study Focus

Healthy Volunteer

Celecoxib 200 mg capsule

Interventional

drug

Sponsor & Location

International Bio service

Timeline & Enrollment

Phase 1

Sep 23, 2024

Oct 04, 2024

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 person
Routine general health check-up of armed forces
Persons encountering health services in other circumstances
Persons encountering health services in other circumstances
Person encountering health services in unspecified circumstances

Data Source

ClinicalTrials.gov

NCT06337422

Non-Device Trial