NCT04465266

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jul 2020

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 10, 2020

Completed
18 days until next milestone

Study Start

First participant enrolled

July 28, 2020

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

February 1, 2022

Status Verified

January 1, 2022

Enrollment Period

24 days

First QC Date

July 2, 2020

Last Update Submit

January 28, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • Cmax

    Maximum plasma concentration of tolperisone

    taken over 4 days per dose

  • Tmax

    Time of maximum plasma concentration of tolperisone

    taken over 4 days per dose

  • AUC

    Area under the curve of tolperisone plasma concentrations

    taken over 4 days per dose

  • T1/2

    Half life of tolperisone

    taken over 4 days per dose

Study Arms (3)

50 mg Tolperisone

EXPERIMENTAL

50 mg tablets (2 days SD, 2 days TID)

Drug: Tolperisone

100 mg of Tolperisone

EXPERIMENTAL

100 mg tablets (2 days SD, 2 days TID)

Drug: Tolperisone

200 mg Tolperisone

EXPERIMENTAL

200 mg tablets (2 days SD, 2 days TID)

Drug: Tolperisone

Interventions

TolperisoneDRUG

tablets

100 mg of Tolperisone200 mg Tolperisone50 mg Tolperisone

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • \- pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Worldwide Clinical Trials Early Phase Services, LLC

San Antonio, Texas, 78217, United States

Location

MeSH Terms

Interventions

Tolperisone

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: sequence randomized
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2020

First Posted

July 10, 2020

Study Start

July 28, 2020

Primary Completion

August 21, 2020

Study Completion

September 1, 2021

Last Updated

February 1, 2022

Record last verified: 2022-01

Locations

US(1)