Conditions: Spasticity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 136
Healthy volunteers: yes

Brief summary:
This is a single-center, partial-blind, randomized, placebo-controlled, parallel design study with a nested crossover comparison to define the ECG effects of tizanidine compared to placebo and the positive control, moxifloxacin, in healthy men and women. The study will be conducted in a Phase 1 unit with sufficient facilities to house subjects as required by the protocol.

Detailed description:

Arms:
arm 1: Oral dose of 2 and 4 milligram (mg) tablets arm 2: Placebo followed by a single dose 400 mg moxifloxacin tablets. arm 3: Single dose of 400 mg moxifloxacin followed by placebo.

Interventions: intervention 1: Tizanidine intervention 2: Placebo intervention 3: Moxifloxacin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: