Status:
COMPLETED
Study in Healthy Male Subjects to Demonstrate Bioequivalence of 1600 μg Selexipag Administered as Eight Tablets of 200 μg or as Single Tablet of 1600 μg
Lead Sponsor:
Actelion
Conditions:
Bioequivalence
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
The primary aim of this study is to demonstrate bioequivalence in the rate and extent of absorption between 1600 μg selexipag test drug (administered orally as film-coated tablets of 1600 μg, twice a ...
Eligibility Criteria
Inclusion
- Signed informed consent in the local language prior to any study-mandated procedure.
- Healthy male subjects aged between 18 and 55 years (inclusive) at Screening.
- No clinically significant findings on the physical examination at Screening.
- Body mass index of 18.0 to 30.0 kg/m\^2 (inclusive) at Screening.
- Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 45-90 beats per minute (all inclusive), measured at Screening.
- 12-lead electrocardiogram without clinically relevant abnormalities, measured at Screening.
- Hematology, clinical chemistry, and urinalysis test results not deviating from the normal range to a clinically relevant extent at Screening.
- Negative results from urine drug screen and alcohol breath test at Screening.
- Ability to communicate well with the investigator, in the local language, and to understand and comply with the requirements of the study.
Exclusion
- Known allergic reactions or hypersensitivity to selexipag or any excipient of the drug formulation used in this study.
- History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion of selexipag.
- Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
- Veins unsuitable for intravenous puncture on either arm (e.g., veins that are difficult to locate, access or puncture; veins with a tendency to rupture during or after puncture).
- Treatment with selexipag or another investigational drug within 1 month prior to Screening or 5 half-lives, whichever is longer.
- History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to Screening.
- Excessive caffeine consumption at Screening.
- Smoking within 3 months prior to Screening and inability to refrain from smoking during the course of the study.
- Previous treatment with any prescribed medications (including vaccines) or over-the-counter medications within 2 weeks prior to first study drug administration.
- Loss of 500 mL or more of blood within 3 months prior to Screening.
- Positive results from the hepatitis serology (hepatitis B antigen and hepatitis C antibodies), except for vaccinated subjects or subjects with past but resolved hepatitis, at Screening.
- Positive results from the human immunodeficiency virus serology at Screening.
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
- Legal incapacity or limited legal capacity at Screening.
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT02206295
Start Date
September 1 2012
End Date
December 1 2012
Last Update
February 3 2025
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