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OpenTrials
Completed

NCT Number: NCT02783183

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

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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Key information

Conditions

Peripheral Nueropathy Pain

Age range

19 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YHD1119

Drug

2 by 2

Other names: Pregabalin 300mg

lyrica

Drug

2 by 2

Other names: Pregabalin 150mg

Primary outcomes

  1. Cmax,ss

    Time frame: 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours

  2. AUCtau

    Time frame: 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours

Secondary outcomes

  1. AUClast,ss

    Time frame: 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours

  2. AUCinf,ss

    Time frame: 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours

  3. Tmax,ss

    Time frame: 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

A Open-label, Radomized, Crossover Clinical Trial to Assess the Pharmacokinetics of Pregabalin CR After Multiple Dosing as Compared to Pregabalin IR in Healthy Male Volunteers

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 26, 2016
Registry last updated
Jan 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.