A Open-label, Randomized, Crossover Study to Assess PK of... | NCT02783183

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

NCT02783183

Sponsor

Yuhan Corporation

Status

Completed

Last Update Posted

Jan 16, 2019Actual

Enrollment

32Actual

Phase

Phase 1

Conditions

Peripheral Nueropathy Pain

Interventions

YHD1119
Lyrica

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Aug 2016Actual

Completion Date

Nov 2016Actual

First Submitted Date

May 23, 2016

First Submission Date that Met QC Criteria

May 23, 2016

First Posted Date

May 26, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2019

Last Update Posted Date

Jan 16, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
YHD1119	Experimental	Pregabalin 300mg	Drug: YHD1119 Drug: Lyrica
Lyrica	Active Comparator	Pregabalin 150mg	Drug: YHD1119 Drug: Lyrica

Interventions

Name	Type	Description	Arm Group Labels	Other Names
YHD1119	Drug	2 by 2	Lyrica YHD1119	Pregabalin 300mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cmax,ss		0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours
AUCtau		0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours

Secondary Outcomes

Measure	Description	Time Frame
AUClast,ss		0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours
AUCinf,ss		0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours
Tmax,ss

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34256964	Derived	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.

ID	Term
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates
D002087	Butyrates
D000144	Acids, Acyclic