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NCT04964050 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL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
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
- lead INDUSTRY
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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