NCT04465266

A Phase 1 PK Study of Tolperisone in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Neurana Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Tolperisone	tablets

Timeline

• Start date: 2020-07-28
• Primary completion: 2020-08-21
• Completion: 2021-09-01
• First posted: 2020-07-10
• Last updated: 2022-02-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study