Clinical trial NCT03261427: Evaluate the Pharmacokinetic Characteristics and Safety/Tolerability of YNP-1807 Compared to Lyrica® After Oral Administration Adult Volunteers
Official title: A Randomized, Open-label, Phase I Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety/Tolerability of YNP-1807 Compared to Lyrica® After Oral Administration in Healthy Adult Volunteers: Part I- Single Dosing/Part II- Multiple Dosing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Yungjin Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-08-25
Enrollment: 17
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Part I : AUClast of Pregabalin
timeFrame: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
measure: Part I : Cmax of Pregabalin
timeFrame: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
measure: Part II : AUCτ,ss of Pregabalin
timeFrame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
measure: Part II : Cmax,ss of Pregabalin
timeFrame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
Secondary outcomes:
measure: Part I : AUCinf of Pregabalin
timeFrame: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
measure: Part I : Tmax of Pregabalin
timeFrame: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
measure: Part I : t1/2 of Pregabalin
timeFrame: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
measure: Part I : Vd/F of Pregabalin
timeFrame: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
measure: Part I : CL/F of Pregabalin
timeFrame: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
measure: Part II : Cmin,ss of Pregabalin
timeFrame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
measure: Part II : AUClast,ss of Pregabalin
timeFrame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
measure: Part II : Tmax,ss of Pregabalin
timeFrame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
measure: Part II : t1/2 of Pregabalin
timeFrame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
measure: Part II : CLss/F of Pregabalin
timeFrame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
measure: Part II : Vdss/F of Pregabalin
timeFrame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
measure: Part II : accumulation ratio(Cmax) of Pregabalin
timeFrame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
measure: Part II : accumulation ratio(AUCτ) of Pregabalin
timeFrame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
state: Yonsei-ro Seodaemun-gu
Study officials:
affiliation: Severance Hospital, Seoul, Korea
name: MinSoo Park, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: