Bioequivalence Study Between Capoten Versus Captopril Reference Product in Healthy Adult Participants Under Fasting Conditions

NCT04878315 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL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 Capoten (test product \[T\]) versus captopril (reference product \[R\]) produced by Mylan Pharmaceuticals Spain, in healthy adult participants under fasting condition. Capoten is the registered trademark of SmithKline Beecham Egypt.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Capoten

Capoten will be administered per the treatment sequence

DRUG

Captopril

Captopril will be administered 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
2022-02-13
Primary Completion
2022-03-25
Completion
2022-03-25

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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 NCT04878315 on ClinicalTrials.gov