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

Conditions: Children with PH due to • Pulmonary arterial hypertension (PAH) • persistent pulmonary hypertension of the newborn (PPHN)
MedDRA version: 14.0Level: LLTClassification code 10037405Term: Pulmonary hypertension primarySystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.0Level: LLTClassification code 10036727Term: Primary pulmonary hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.0Level: LLTClassification code 10053592Term: Newborn persistent pulmonary hypertensionSystem Organ Class: 10010331 - Congenital, familial and genetic disorders

Registration Number: EUCTR2011-001893-24-DE

Lead Sponsor: Bayer HealthCare AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>;Secondary Objective: Secondary objectives are safty and tolerability measured by the parameters in section 7.4.3. and adverse events. ;Primary end point(s):

Secondary Outcome Measures