Evaluate the Pharmacokinetic Characteristics and Safety/Tolerability of YNP-1807 Compared to Lyrica® After Oral Administration Adult Volunteers
- Registration Number
- NCT03261427
- Lead Sponsor
- Yungjin Pharm. Co., Ltd.
- Brief Summary
The purpose of this trial to compare the pharmacokinetic characteristics of YNP-1807(Pregabalin 330mg) and Lyrica capsule(Pregabalin 150mg). YNP-1807 is made by Yungjin Pharm. Primary endpoints are AUClast and Cmax and secondary endpoints are AUCinf, Tmax, t1/2, Vd/f, CL/f.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
Inclusion Criteria
-
19 years to 55 years healthy volunteers adult at screening visit
-
For male, weight is more than 55 kg, for female, weight is more than 50 kg.
-
Body mass index(BMI) value : 18.5 to 25.0 kg/m2
-
If female, should be included one at least as following
- menopausal(menstruation for 2 years minimum)
- surgery infertility
Exclusion Criteria
- Any history of drug overdose or dependence
- Female who is pregnant or nursing
- AST, ALT > ULN*1.25
- Total bilirubin > ULN*1.5
- CPK > ULN*1.5
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Lyrica Capsule(Pregabalin 150mg) Lyrica 150Mg Capsule Lyrica Capsule(Pregabalin 150mg), BID YNP-1807 Tablet(Pregabalin 330mg) YNP-1807 330Mg Tablet YNP-1807(Pregabalin 330mg), QD
- Primary Outcome Measures
Name Time Method Part I : AUClast of Pregabalin 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours Part II : Cmax,ss of Pregabalin Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours Part I : Cmax of Pregabalin 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours Part II : AUCτ,ss of Pregabalin Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
- Secondary Outcome Measures
Name Time Method Part II : t1/2 of Pregabalin Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours Part I : Vd/F of Pregabalin 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours Part I : t1/2 of Pregabalin 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours Part I : CL/F of Pregabalin 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours Part I : AUCinf of Pregabalin 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours Part II : Cmin,ss of Pregabalin Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours Part I : Tmax of Pregabalin 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours Part II : Tmax,ss of Pregabalin Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours Part II : AUClast,ss of Pregabalin Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours Part II : CLss/F of Pregabalin Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours Part II : Vdss/F of Pregabalin Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours Part II : accumulation ratio(Cmax) of Pregabalin Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours Part II : accumulation ratio(AUCτ) of Pregabalin Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
Trial Locations
- Locations (1)
Severance Hospital
🇰🇷Seoul, Yonsei-ro Seodaemun-gu, Korea, Republic of