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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1
Seoul ST.Mary Hospital
Seoul, South Korea