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The Bioequivalence Study of Alfuzosin 10 mg Prolong-released Tablets Under Fed Conditions - Trial NCT06228339

Access comprehensive clinical trial information for NCT06228339 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 44 participants.

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NCT06228339
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov • NCT06228339
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The Bioequivalence Study of Alfuzosin 10 mg Prolong-released Tablets Under Fed Conditions
A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets and Reference Product (Xatral® XL 10 mg) in Healthy Thai Male Volunteers Under Fed Conditions

Study Focus

Healthy Volunteer

Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets

Interventional

drug

Sponsor & Location

International Bio service

Timeline & Enrollment

Phase 1

Mar 09, 2024

Mar 21, 2024

44 participants

Primary Outcome

Plasma Area Under the Curve (AUC(0 to 48hr)) for Alfuzosin,Peak Plasma Concentration (Cmax) of Alfuzosin

Summary

Objective:
 
 Primary objective of the present study was to assess the relative bioavailability of
 Alfuzosin 10 mg Prolong-released Tablets under Fed conditions, in Healthy Thai Male
 Volunteers after an oral administration with 7 days washout period.
 
 Study Design:
 
 A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study

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

NCT06228339

Non-Device Trial