PK and Food Effect of Pregabalin Study After Dosing in Healthy Male Volunteers

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

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-09-30

Brief Summary

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This study is to assess the pharmacokinetics of Pregabalin controlled release formulation after multiple dosing as compared to Pregabalin immediate release formulation and the food effect of high fat diet after single dosing in healthy male volunteers.

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Detailed Description

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Cohort 1 study is to assess the PK of Pregabalin controlled release formulation as compared to Pregabalin immediate release formulation. Cohort 1 subjects will be admitted to the clinic at Day 1. All subjects will receive multiple dosing for three days of YHD1119 or Pregabalin IR and will remain in the clinic until completion of all assessment on Day 19 including collection of PK sample. The treatment periods were separated by a washout period (10-17 days).

Cohort 2 study is to assess the food effect of high fat diet after single dosing. Cohort 2 subjects will be admitted to the clinic at Day -1. All subjects will receive a single dose of YHD1119 and will remain in the clinic until completion of all assessment on Day 9 including collection of PK sample. The treatment periods were separated by a washout period (7-14 days).

Conditions

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Peripheral Neuropathy Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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YHD1119 (Pregabalin 300mg)

Group Type EXPERIMENTAL

YHD1119

Intervention Type DRUG

2 by 2

Lyrica (Pregabalin 150mg)

Group Type ACTIVE_COMPARATOR

Lyrica

Intervention Type DRUG

2 by 2

Interventions

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YHD1119

2 by 2

Intervention Type DRUG

Lyrica

2 by 2

Intervention Type DRUG

Other Intervention Names

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Pregabalin 300mg Pregabalin 150mg

Eligibility Criteria

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Inclusion Criteria

* Healthy male with body mass index (BMI) between 18.5 and 28 kg/m2
* Who has not suffered from clinically significant disease
* Provision of signed written informed consent

Exclusion Criteria

* History of and clinically significant disease
* A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
* Administration of other investigational products within 3 months prior to the first dosing

Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes