Randomized, Open-label, Parallel Study to Evaluate the Pharmacokinetic Characteristics of Pregabalin According to Different Controlled Released Formulations in Healthy Male Subjects
- Registration Number
- NCT01420913
- Lead Sponsor
- Yuhan Corporation
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 28
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description YHD1119 C(Pregabalin SR 300mg) Pregabalin - Lyrica capsule(Pregabalin 150mg) Pregabalin - YHD1119 A(Pregabalin SR 300mg) Pregabalin - YHD1119 B(Pregabalin SR 300mg) Pregabalin -
- Primary Outcome Measures
Name Time Method Cmax,ss 36 hr AUCtau 36 hr Safety monitoring 14 days Laboratory findings Adverse event
- Secondary Outcome Measures
Name Time Method AUClast AUCinfinity Tmax,ss t1/2 36 hour AUCinfinity 36 hr Tmax,ss 36 hr t 1/2 36 hr
Trial Locations
- Locations (1)
Seoul ST.Mary Hospital
🇰🇷Seoul, Korea, Republic of