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Bioequivalence Study of Diacerein 50 mg Capsule in Healthy Thai Volunteers - Trial NCT06308068

Access comprehensive clinical trial information for NCT06308068 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 30 participants.

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NCT06308068
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06308068
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Bioequivalence Study of Diacerein 50 mg Capsule in Healthy Thai Volunteers
A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Diacerein 50 mg Capsule and Reference Product (ARTRODARยฎ) in Healthy Thai Volunteers Under Fed Conditions

Study Focus

Healthy Volunteer

Diacerein 50 mg Capsule

Interventional

drug

Sponsor & Location

International Bio service

Timeline & Enrollment

Phase 1

Jul 30, 2024

Aug 18, 2024

30 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
 fed 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

NCT06308068

Non-Device Trial