A single-center, open-label, randomized, two-period, two-treatment, crossover study in healthy male subjects to demonstrate bioequivalence of 1600 mcg selexipag administered as eight tablets of 200 mcg (reference drug) or as single tablet of 1600 mcg (test drug)
Completed
- Conditions
- pulmonary arterial hypertension10037454
- Registration Number
- NL-OMON37306
- Lead Sponsor
- Actelion Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 124
Inclusion Criteria
• Healthy male subjects aged between 18 and 55 years (inclusive)
• No clinically significant findings at Screening.
• Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at Screening.
• Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate (PR) 45-90 bpm (inclusive);Refer to protocol for complete list of inclusion criteria
Exclusion Criteria
• Known allergic reactions or hypersensitivity to selexipag
• History or clinical evidence of any clinical significant disease and/or existence of any surgical or medical condition.
• History or clinical evidence of alcoholism or drug abuse
• Excessive caffeine consumption;Refer to protocol for a complete list of exclusion criteria
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacokinetics</p><br>
- Secondary Outcome Measures
Name Time Method <p>Safety and tolerability</p><br>