Trial Condition(s):

Pharmacology, clinical

Relative bioavailability and food effect study

Bayer Identifier:

14986

ClinicalTrials.gov Identifier:

NCT01489488

EudraCT Number:

2011-001893-24

Study Completed

Trial Purpose

Primary objective: To determine oral bioavailability of the liquid formulation intended for pediatric use and potential food effects in healthy adults.
Secondary objective: To evaluate safety and tolerability measured by physical examination findings, vital signs, electrocardiogram (ECG), laboratory parameters, and adverse events (AEs).

Inclusion Criteria
- Healthy male or female volunteers
 - Age 18-45 years
 - Body mass index (BMI) 18.0-29.9 kg/m²
 - Systolic blood pressure (SBP) 110-145 mmHg
 - No drugs 2 weeks before treatment
 - Nonsmokers for at least 12 weeks
Exclusion Criteria
- Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
 - Medical disorder that would impair the subject's ability to complete the study in the opinion of the Investigator
 - Known hypersensitivity to the study drugs (active substance or excipients of the preparations)
 - Known severe allergies, non-allergic drug reactions, or multiple drug allergies
 - Relevant diseases within the last 4 weeks prior to the first study drug administration
 - Regular use of medicines
 - Regular use of therapeutic or recreational drugs
 - Use of any medication within the 2 weeks preceding the study

Trial Summary

Enrollment Goal
32
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Adempas (Riociguat, BAY63-2521)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

MEDA Manufacturing GmbH, ClinPharmCologne

Köln, Germany, 51063

Status
Completed
 

Trial Design