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

• Status: Completed
• Trial end date: 2018-03-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Yungjin Pharm. Co., Ltd.
• Treatments: Pregabalin

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