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Completed

NCT Number: NCT01420913

Randomized, Open-label, Parallel Study to Evaluate the Pharmacokinetic Characteristics of Pregabalin According to Different Controlled Released Formulations in Healthy Male Subjects

The purpose of this trial is to compare the pharmacokinetic characteristics of YHD1119 A, YHD1119 B, YHD1119 C and Lyrica capsule.

YHD1119 A, B, C are controlled released formulations which are made by YUHAN Corporation.

Primary endpoints are C max,ss and AUC tau. Secondary endpoints are AUC last, AUC infinity, T max,ss, t 1/2

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Seoul ST.Mary Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 20~45 years old, healthy adult male subject
  • >55 Kg(Body weight) and < ideal body weight ± 20%

Exclusion criteria

  • AST or ALT > 1.25 * Upper normal range (Lab)
  • Total bilirubin > 1.5 * Upper normal range
  • Systolic BP >140 OR <100, Diastolic BP >90 OR <65

Treatment and study plan

Pregabalin

Drug

Pregabalin 300mg a day

Primary outcomes

  1. Cmax,ss

    Time frame: 36 hr

  2. AUCtau

    Time frame: 36 hr

  3. Safety monitoring

    Time frame: 14 days

    Laboratory findings Adverse event

Secondary outcomes

  1. AUClast AUCinfinity Tmax,ss t1/2

    Time frame: 36 hour

  2. AUCinfinity

    Time frame: 36 hr

  3. Tmax,ss

    Time frame: 36 hr

  4. t 1/2

    Time frame: 36 hr

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

Randomized,Open-label,Parallel Study to Evaluate the Pharmacokinetic Characteristics of Pregabalin According to Different Controlled Released Formulations in Healthy Male Subjects

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 22, 2011
Registry last updated
Aug 22, 2011

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.

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