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Completed

NCT Number: NCT04465266

A Phase 1 PK Study of Tolperisone in Healthy Subjects

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

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Key information

Conditions

Healthy

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Worldwide Clinical Trials Early Phase Services, LLC

San Antonio, Texas, 78217, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • pregnant or breastfeeding

Treatment and study plan

Tolperisone

Drug

tablets

Primary outcomes

  1. Cmax

    Time frame: taken over 4 days per dose

    Maximum plasma concentration of tolperisone

  2. Tmax

    Time frame: taken over 4 days per dose

    Time of maximum plasma concentration of tolperisone

  3. AUC

    Time frame: taken over 4 days per dose

    Area under the curve of tolperisone plasma concentrations

  4. T1/2

    Time frame: taken over 4 days per dose

    Half life of tolperisone

Sponsors and collaborators

Lead sponsor

Neurana Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jul 10, 2020
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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