Single Dose Bioequivalence Study Comparing Nifedipine/Candesartan FDC (Fixed Dose Combination) With Loose Combination of Nifedipine GITS (Gastro-intestinal Therapeutic System) Plus Candesartan and Single Components Under Fasting Conditions
Single Dose Study to Compare the Pharmacokinetics as Well as Safety and Tolerability of a Novel Fixed Dose Combination of Nifedipine GITS and Candesartan, the Loose Combination of Both and the Single Components Alone and to Investigate the Bioequivalence Between the Fixed Dose and the Loose Combination in Healthy Male Volunteers Under Fasting Conditions in an Open Label, Randomized, 4-way-crossover Design
Sponsor: Bayer
This PHASE1 trial investigates Hypertension, Essential and is currently completed. Bayer leads this study, which shows 6 recorded versions since 2010 — indicating limited longitudinal coverage. Heart and vascular conditions benefit from the kind of long-term tracking this trial provides.
Status Flow
Change History
6 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE1
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Sep 2024 — Sep 2025 [monthly]
Completed PHASE1
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE1
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE1
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE1
▶ Show 1 earlier version
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Jan 2017 — Jun 2018 [monthly]
Completed PHASE1
First recorded
Nov 2010
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Bayer
For direct contact, visit the study record on ClinicalTrials.gov .