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NCT06228339

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
International Bio service·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Healthy Volunteer
Drug/Device/Intervention
Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
International Bio service
Timeline & enrollment
Phase
Phase 1
Start date
Mar 09, 2024
End date
Mar 21, 2024
Enrollment
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 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
NCT06228339
Type
Non-Device Trial
About this record

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.

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.