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Clinical Trials/EUCTR2010-020197-42-DE
EUCTR2010-020197-42-DE
Active, not recruiting
Not Applicable

Evaluation of the pharmacokinetics, pharmacodynamics and safety of repeated escalating oral doses of a slow release formulation of S 38844 in healthy male volunteersAn open-label, non-randomised, two-group three-period, monocentre study

Institut de Recherches Internationales Servier0 sites27 target enrollmentMay 27, 2010
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Institut de Recherches Internationales Servier
Enrollment
27
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 27, 2010
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Male

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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