A Phase 1 PK Study of Tolperisone in Healthy Subjects

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04465266
• Other study ID #: CLN-110
• Status: Completed
• Phase: Phase 1
• Start date: July 28, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: January 2022
• Source: Neurana Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 1, 2021
• Est. primary completion date: August 21, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Generally Healthy Subjects

• BMI between 18.5 and 32.5 kg/m2

Exclusion Criteria:

• pregnant or breastfeeding

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Tolperisone
tablets

Locations

Country	Name	City	State
United States	Worldwide Clinical Trials Early Phase Services, LLC	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Neurana Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Maximum plasma concentration of tolperisone	taken over 4 days per dose
Primary	Tmax	Time of maximum plasma concentration of tolperisone	taken over 4 days per dose
Primary	AUC	Area under the curve of tolperisone plasma concentrations	taken over 4 days per dose
Primary	T1/2	Half life of tolperisone	taken over 4 days per dose