To determine oral bioavailability of the oral liquid formulation and potential food effects.

Relative bioavailability and food effect study of two oral liquid formulations in comparison to a 1mg 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

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001893-24-DE

Enrollment

Registered

2011-09-21

Start date

2011-10-13

Completion date

Unknown

Last updated

2013-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children with PH due to • Pulmonary arterial hypertension (PAH) • persistent pulmonary hypertension of the newborn (PPHN) MedDRA version: 14.0 Level: LLT Classification code 10037405 Term: Pulmonary hypertension primary System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0 Level: LLT Classification code 10036727 Term: Primary pulmonary hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.0

Interventions

Product Name: BAY 63-2521 0.3 % Product Code: BAY 63-2521 Pharmaceutical Form: Granules for oral suspension INN or Proposed INN: Riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY 63-2521 Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy male or female volunteers, age 18-45 years, BMI 18.0-29.9 kg/m², SBP 110-145 mmHg, no drugs 2 weeks before treatment, non-smokers for at least 12 weeks Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to determine oral bioavailability of the liquid formulation intended for paediatric use and potential food effects in healthy adults. ;Secondary Objective: Secondary objectives are safty and tolerability measured by the parameters in section 7.4.3. and adverse events. ;Primary end point(s):	—

Countries

Germany

Contacts

Public ContactBayer Clinical Trials Contact

Bayer HealthCare AG

clinical-trials-contact@bayerhealthcare.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026