NCT01420913CompletedPhase 1
Randomized,Open-label,Parallel Study to Evaluate the Pharmacokinetic Characteristics of Pregabalin According to Different Controlled Released Formulations in Healthy Male Subjects
Yuhan Corporation1 site in 1 country28 target enrollmentStarted: August 2011Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Cmax,ss
Study Overview
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 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Lyrica capsule(Pregabalin 150mg)
Active Comparator
Intervention: Pregabalin (Drug)
YHD1119 A(Pregabalin SR 300mg)
Experimental
Intervention: Pregabalin (Drug)
YHD1119 B(Pregabalin SR 300mg)
Experimental
Intervention: Pregabalin (Drug)
YHD1119 C(Pregabalin SR 300mg)
Experimental
Intervention: Pregabalin (Drug)
Outcomes
Primary Outcomes
Cmax,ss
Time Frame: 36 hr
AUCtau
Time Frame: 36 hr
Safety monitoring
Time Frame: 14 days
Laboratory findings Adverse event
Secondary Outcomes
- AUClast AUCinfinity Tmax,ss t1/2(36 hour)
- AUCinfinity(36 hr)
- Tmax,ss(36 hr)
- t 1/2(36 hr)
Investigators
Study Sites (1)
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