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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