Evaluate the Pharmacokinetic Characteristics and Safety/Tolerability of YNP-1807 Compared to Lyrica® After Oral Administration Adult Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03261427

Enrollment

Registered

2017-08-25

Start date

2017-09-14

Completion date

2018-03-29

Last updated

2019-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGLyrica 150Mg Capsule

150 mg oral administered (BID)

DRUGYNP-1807 330Mg Tablet

330 mg oral administered (QD)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Part I : AUClast of Pregabalin	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
Part II : Cmax,ss of Pregabalin	Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

Secondary

Measure	Time frame
Part I : CL/F 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 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 : Tmax,ss of Pregabalin	Pre-dose, 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 : 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
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 : Tmax 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 : Vd/F of Pregabalin	0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026