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A Phase 1 PK Study of Tolperisone in Healthy Subjects

NCT ID: NCT04465266

Last Updated: 2022-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-28

Study Completion Date

2021-09-01

Brief Summary

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

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Detailed Description

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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

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

sequence randomized
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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50 mg Tolperisone

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

Group Type EXPERIMENTAL

Tolperisone

Intervention Type DRUG

tablets

100 mg of Tolperisone

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

Group Type EXPERIMENTAL

Tolperisone

Intervention Type DRUG

tablets

200 mg Tolperisone

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

Group Type EXPERIMENTAL

Tolperisone

Intervention Type DRUG

tablets

Interventions

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Tolperisone

tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- pregnant or breastfeeding
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Neurana Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Worldwide Clinical Trials Early Phase Services, LLC

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CLN-110

Identifier Type: -

Identifier Source: org_study_id

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