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

Yungjin Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Lyrica 150Mg Capsule; Drug: YNP-1807 330Mg Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT03261427

YJ16-101

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

17 participants in 2 patient groups

YNP-1807 Tablet(Pregabalin 330mg)

Experimental group

Description:

YNP-1807(Pregabalin 330mg), QD

Treatment:

Drug: YNP-1807 330Mg Tablet

Lyrica Capsule(Pregabalin 150mg)

Active Comparator group

Description:

Lyrica Capsule(Pregabalin 150mg), BID

Treatment:

Drug: Lyrica 150Mg Capsule