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A Open-label, Randomized, Crossover Study to Assess PK of Pregabalin

NCT ID: NCT02783183

Last Updated: 2019-01-16

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-11-30

Brief Summary

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The purpose of this trial to compare the pharmacokinetic characteristics of YHD1119(Pregabalin 300mg) and Lyrica capsule(Pregabalin 150mg). YHD1119 is controlled release formulation which is made by Yuhan Corporation. Primary endpoints are Cmax,ss and AUCtau and secondary endpoints are AUClast,ss, AUCinf,ss, Tmax,ss and t1/2.

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Detailed Description

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Conditions

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Peripheral Nueropathy 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

Intervention Type DRUG

2 by 2

Lyrica

Pregabalin 150mg

Group Type ACTIVE_COMPARATOR

YHD1119

Intervention Type DRUG

2 by 2

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

* 19\~50 years old, healthy male volunteers
* \>55Kg(Body weight) and 18.5\<BMI\<28

Exclusion Criteria

* AST or ALT \> 3 \* Upper normal range (Lab)
* Total bilirubin \> 2.0 mg/dl
* Systolic BP \>140 OR \<90, Diastolic BP \>100 OR \<60
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Yuhan Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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Moon SJ, Jeon JY, Lim Y, An T, Jang SB, Kim S, Na WS, Lee SY, Kim MG. Pharmacokinetics of a New, Once-Daily, Sustained-release Pregabalin Tablet in Healthy Male Volunteers. Clin Ther. 2021 Aug;43(8):1381-1391.e1. doi: 10.1016/j.clinthera.2021.06.010. Epub 2021 Jul 11.

Reference Type DERIVED
PMID: 34256964 (View on PubMed)

Other Identifiers

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YHD1119-103

Identifier Type: -

Identifier Source: org_study_id

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