NCT01489488

Relative Bioavailability and Food Effect Study

Relative Bioavailability and Food Effect Study of Two Oral Liquid Formulations in Comparison to a 1 mg Tablet of Riociguat to Characterize Its Pharmacokinetic Properties in Healthy Male and Female Adult Subjects in a Randomized, Open Label, 5-fold Crossover Design

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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).

Detailed description

Clinical pharmacology

Conditions

• Pharmacology, Clinical

Interventions

Type	Name	Description
DRUG	Riociguat (BAY63-2521)	Single oral dose of 2.4 milligram (mg) riociguat (BAY63-2521) as pediatric high-concentration suspension (0.15 mg per milliliter \[mg/mL\], i.e. 16 mL) under fasting conditions
DRUG	Riociguat (BAY63-2521)	Single oral dose of 2.4 mg riociguat as pediatric high-concentration suspension (0.15 mg/mL, i.e. 16 mL) under fed conditions
DRUG	Riociguat (BAY63-2521)	Single oral dose of 0.3 mg riociguat as pediatric high-concentration suspension (0.15 mg/mL, i.e. 2 mL) under fasting conditions
DRUG	Riociguat (BAY63-2521)	Single oral dose of 0.15 mg riociguat as pediatric low-concentration suspension (0.03 mg/mL, i.e. 5 mL) under fasting conditions
DRUG	Riociguat (BAY63-2521)	Single oral dose of riociguat immediate release (IR) tablet 1 mg under fasting conditions

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-04-01
• Completion: 2012-05-01
• First posted: 2011-12-09
• Last updated: 2015-07-01

Locations

1 site across 1 country: Germany