muscle spasm MedDRA version: 9.1 Level: HLGT Classification code 10028393 Term: Musculoskeletal and connective tissue disorders NEC
Conditions
Interventions
Trade Name: TIOSIDE*20CPS RIG 4MG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Thiocolchicoside
Concentration unit: IU/mg international unit(s)/milligram
Concentration type: equal
Concentra
Sponsors
MUTUAL PHARMACEUTICAL COMPANY
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Italy
Outcome results
None listed