Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT04964050

A Bioequivalence Study Between Capozide Versus ACE-Hemmer-ratiopharm in Healthy Adult Participants Under Fasting Conditions

An Open-label, Randomized Three Period, Three Sequence, Partially Replicated Crossover Bioequivalence Study of Two Oral Formulations of Captopril/Hydrochlorothiazide 50/25 mg Tablets in Healthy Adult Participants Under Fasting Conditions

Status
Withdrawn
Phase
Phase 1
Study type
Interventional
Enrollment
0 (actual)
Sponsor
GlaxoSmithKline · Industry
Sex
All
Age
18 Years – 50 Years
Healthy volunteers
Accepted

Summary

This is a bioequivalence study to compare Capozide (test product \[T\]) to ACE-Hemmer-ratiopharm (reference product\[R\]) produced by Ratiopharm GmbH Germany in healthy adult participants under fasting conditions. ACE-Hemmer-ratiopharm®is the registered trademark of Ratiopharm GmbH Germany.

Conditions

Interventions

TypeNameDescription
DRUGCapozideCapozide will be administered as per the treatment sequence.
DRUGACE-Hemmer-RatiopharmACE-Hemmer-Ratiopharm will be administered as per the treatment sequence.

Timeline

Start date
2022-04-21
Primary completion
2022-05-26
Completion
2022-05-26
First posted
2021-07-15
Last updated
2023-01-27

Source: ClinicalTrials.gov record NCT04964050. Inclusion in this directory is not an endorsement.