A Phase 1 PK Study of Tolperisone in Healthy Subjects

Neurana Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Tolperisone

Study type: Interventional

Funder types: Industry

Identifiers

NCT04465266

CLN-110

Details and patient eligibility

About

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

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• pregnant or breastfeeding

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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27 participants in 3 patient groups

50 mg Tolperisone

Experimental group

Description:

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

Treatment:

Drug: Tolperisone

100 mg of Tolperisone

Experimental group

Description:

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

Treatment:

Drug: Tolperisone

200 mg Tolperisone

Experimental group

Description:

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

Treatment:

Drug: Tolperisone