Randomized, Open-label, Parallel Study to Evaluate the Pharmacokinetic Characteristics of Pregabalin According to Different Controlled Released Formulations in Healthy Male Subjects
NCT ID: NCT01420913
Last Updated: 2011-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2011-08-31
2011-08-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Lyrica capsule(Pregabalin 150mg)
Pregabalin
Pregabalin 300mg a day
YHD1119 A(Pregabalin SR 300mg)
Pregabalin
Pregabalin 300mg a day
YHD1119 B(Pregabalin SR 300mg)
Pregabalin
Pregabalin 300mg a day
YHD1119 C(Pregabalin SR 300mg)
Pregabalin
Pregabalin 300mg a day
Interventions
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Pregabalin
Pregabalin 300mg a day
Eligibility Criteria
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Inclusion Criteria
* \>55 Kg(Body weight) and \< ideal body weight ± 20%
Exclusion Criteria
* Total bilirubin \> 1.5 \* Upper normal range
* Systolic BP \>140 OR \<100, Diastolic BP \>90 OR \<65
20 Years
45 Years
MALE
Yes
Sponsors
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Yuhan Corporation
INDUSTRY
Responsible Party
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Locations
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Seoul ST.Mary Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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YCD207
Identifier Type: -
Identifier Source: org_study_id
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