Evaluation of blood drug level profile, effect and safety after repeated administration of a slow release formulation of S-38844 in healthy male volunteers
- Conditions
- Cardiovascular DiseasesMedDRA version: 13.1Level: LLTClassification code 10007648Term: Cardiovascular disease, unspecifiedSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2010-020197-42-DE
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 27
Inclusion Criteria
- Caucasian male healthy volunteers;
- Age between 55 and 65 years;
- Absence of diseases and medical history incompatible with the study protocol.
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 8
Exclusion Criteria
History of major medical disease, psychiatric disorder or surgery likely to interfere with the handling of the study drug;
History of personal or familial Long QT Syndrome;
Acute or chronic systemic disorder;
History of drug hypersensitivity.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method