A Phase 1 PK Study of Tolperisone in Healthy Subjects

A Phase 1 Crossover Study of Single and Multiple Dose Pharmacokinetics, and Dose Linearity, of Tolperisone in Healthy Subjects

This is a randomized, single-blind, single and multiple dose crossover subjects in healthy adult subjects

This is a single-center, in-patient, treatment sequence-randomized, single-blind SD and MD crossover study in 27 healthy adult male and female subjects. Subjects will be admitted to the clinic on Day-1 and discharged the morning of Day 5 of each treatment period. Subjects will be on a standard diet during each inpatient treatment period; study drug will be administered in the fasted state for PK assessments on Days 1 and 4 of each treatment period. Subjects will have a follow-up phone call 7 to 10 days after the last dose in Period 3. There will be a 6 to 8 day washout between the last dose in Period 1 and the first dose in Period 2, and between the last dose in Period 2 and the first dose in Period 3.

Inclusion Criteria:

• Generally Healthy Subjects
• BMI between 18.5 and 32.5 kg/m2

Exclusion Criteria:

- pregnant or breastfeeding