A Phase 1 PK Study of Tolperisone in Healthy Subjects
Overview
This is a randomized, single-blind, single and multiple dose crossover subjects in healthy adult subjects
Full Title of Study: “A Phase 1 Crossover Study of Single and Multiple Dose Pharmacokinetics, and Dose Linearity, of Tolperisone in Healthy Subjects”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Other
- Masking: Single (Participant)
- Study Primary Completion Date: August 21, 2020
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.
Interventions
- Drug: Tolperisone
- tablets
Arms, Groups and Cohorts
- Experimental: 50 mg Tolperisone
- 50 mg tablets (2 days SD, 2 days TID)
- Experimental: 100 mg of Tolperisone
- 100 mg tablets (2 days SD, 2 days TID)
- Experimental: 200 mg Tolperisone
- 200 mg tablets (2 days SD, 2 days TID)
Clinical Trial Outcome Measures
Primary Measures
- Cmax
- Time Frame: taken over 4 days per dose
- Maximum plasma concentration of tolperisone
- Tmax
- Time Frame: taken over 4 days per dose
- Time of maximum plasma concentration of tolperisone
- AUC
- Time Frame: taken over 4 days per dose
- Area under the curve of tolperisone plasma concentrations
- T1/2
- Time Frame: taken over 4 days per dose
- Half life of tolperisone
Participating in This Clinical Trial
Inclusion Criteria
- Generally Healthy Subjects – BMI between 18.5 and 32.5 kg/m2 Exclusion Criteria:
- pregnant or breastfeeding
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 64 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Neurana Pharmaceuticals, Inc.
- Provider of Information About this Clinical Study
- Sponsor
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