Status:

COMPLETED

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

Lead Sponsor:

Yuhan Corporation

Conditions:

Healthy

Eligibility:

MALE

20-45 years

Phase:

PHASE1

Brief Summary

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 ...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

August 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2011

Estimated Enrollment :

28 Patients enrolled

Trial Details

Trial ID

NCT01420913

Start Date

August 1 2011

End Date

August 1 2011

Last Update

August 22 2011

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Seoul ST.Mary Hospital

Seoul, South Korea