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)

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) - Selexipag / ACT-293987 bioequivalence study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON37306

Enrollment

124

Registered

2012-08-28

Start date

2012-09-28

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

pulmonary arterial hypertension

Interventions

The study will start with a screening At the screening a physical examination will take place and a few other standard medical assessments will be performed (Vital Signs, ECG). Furthermore a blood a

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics	—

Secondary

Measure	Time frame
Safety and tolerability	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)