Trial Condition(s):

Clinical Pharmacology

Single dose escalation study to investigate the pharmacokinetics as well as safety and tolerability of a concomitant administration of nifedipne GITS and candesartan tablets under fasting conditions in healthy male subjects in an open label, non-randomized, sequential design.

Bayer Identifier:

14026

ClinicalTrials.gov Identifier:

NCT03136666

EudraCT Number:

2010-018958-12

Study Completed

Trial Purpose

The objective of the study was to investigate the pharmacokinetics as well as safety and tolerability of a concomitant administration of nifedipine GITS and candesartan tablets under fasting conditions in healthy male subjects.

Inclusion Criteria
:
 -  Healthy male volunteers
 -  Age 30-55 years
 -  BMI 18.0-29.9 kg/m²
 -  Systolic blood pressure (SBP) ≥ 120 and ≤ 145 mmHg
Exclusion Criteria
No Exclusion Criteria Available

Trial Summary

Enrollment Goal
12
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Wuppertal, Germany, 42096

Status
Completed
 

Trial Design