A SINGLE BLIND, SINGLE DOSE STUDY OF THE SEDATIVE EFFECTS OF THIOCOLCHICOSIDE, TIZANIDINE AND CYCLOBENZAPRINE IN HEALTHY MALE, HUMAN VOLUNTEERS - TCC-C-001
- Conditions
- muscle spasmMedDRA version: 9.1Level: HLGTClassification code 10028393Term: Musculoskeletal and connective tissue disorders NEC
- Registration Number
- EUCTR2008-004665-25-IT
- Lead Sponsor
- MUTUAL PHARMACEUTICAL COMPANY
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria
HEALTHY MALE VOLUNTEERS,18-40 YEARS, NORMAL HISTORY AND PHYSICAL EXAMINATION NORMAL LAB TESTS LESS THAN 18 UNITS ALCOHOL/WEEK WRITTEN INFORMED CONSENT
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
Exclusion Criteria
CURRENT ADMINISTRATION OF ANY MEDICATION ON A CHRONIC BASIS, CLINICALLY SIGNIFICANT CONCOMITANT SDIEASES, MORE THAN 10 SIGARETTE/DAY, INVESTIGAT.COMP,6 MONTH PRIOR TO STUDY, LACK OF INFORMED CONSENSE
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: EXTENT OF SEDATION INDUCED BY THE THREE STUDY DRUGS IN COMPARISON WITH PLACEBO;Secondary Objective: NONE;Primary end point(s): EXTENT OF SEDATION INDUCED BY THE THREE STUDY DRUGS IN COMPARISON WITH PLACEBO
- Secondary Outcome Measures
Name Time Method