Relative Bioavailability and Food Effect Study

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Treatments: Riociguat

Criteria

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