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

NCT04964050 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-01-27

No results posted yet for this study

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

  • Healthy Volunteers

Interventions

DRUG

Capozide

Capozide will be administered as per the treatment sequence.

DRUG

ACE-Hemmer-Ratiopharm

ACE-Hemmer-Ratiopharm will be administered as per the treatment sequence.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-21
Primary Completion
2022-05-26
Completion
2022-05-26

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04964050 on ClinicalTrials.gov