A Phase 1 PK Study of Tolperisone in Healthy Subjects
- Registration Number
- NCT04465266
- Lead Sponsor
- Neurana Pharmaceuticals, Inc.
- Brief Summary
This is a randomized, single-blind, single and multiple dose crossover subjects in healthy adult subjects
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
- Generally Healthy Subjects
- BMI between 18.5 and 32.5 kg/m2
- pregnant or breastfeeding
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 50 mg Tolperisone Tolperisone 50 mg tablets (2 days SD, 2 days TID) 100 mg of Tolperisone Tolperisone 100 mg tablets (2 days SD, 2 days TID) 200 mg Tolperisone Tolperisone 200 mg tablets (2 days SD, 2 days TID)
- Primary Outcome Measures
Name Time Method Tmax taken over 4 days per dose Time of maximum plasma concentration of tolperisone
Cmax taken over 4 days per dose Maximum plasma concentration of tolperisone
AUC taken over 4 days per dose Area under the curve of tolperisone plasma concentrations
T1/2 taken over 4 days per dose Half life of tolperisone
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Worldwide Clinical Trials Early Phase Services, LLC
🇺🇸San Antonio, Texas, United States