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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 Diseases
MedDRA version: 13.1Level: LLTClassification code 10007648Term: Cardiovascular disease, unspecifiedSystem Organ Class: 10007541 - Cardiac disorders
Therapeutic 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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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