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Completed

NCT Number: NCT03261427

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

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.

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Key information

Conditions

Healthy

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Severance Hospital

Seoul, Yonsei-ro Seodaemun-gu, 120-752, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lyrica 150Mg Capsule

Drug

150 mg oral administered (BID)

YNP-1807 330Mg Tablet

Drug

330 mg oral administered (QD)

Primary outcomes

  1. Part I : AUClast of Pregabalin

    Time frame: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  2. Part I : Cmax of Pregabalin

    Time frame: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  3. Part II : AUCτ,ss of Pregabalin

    Time frame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  4. Part II : Cmax,ss of Pregabalin

    Time frame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

Secondary outcomes

  1. Part I : AUCinf of Pregabalin

    Time frame: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  2. Part I : Tmax of Pregabalin

    Time frame: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  3. Part I : t1/2 of Pregabalin

    Time frame: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  4. Part I : Vd/F of Pregabalin

    Time frame: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  5. Part I : CL/F of Pregabalin

    Time frame: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  6. Part II : Cmin,ss of Pregabalin

    Time frame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  7. Part II : AUClast,ss of Pregabalin

    Time frame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  8. Part II : Tmax,ss of Pregabalin

    Time frame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  9. Part II : t1/2 of Pregabalin

    Time frame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  10. Part II : CLss/F of Pregabalin

    Time frame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  11. Part II : Vdss/F of Pregabalin

    Time frame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  12. Part II : accumulation ratio(Cmax) of Pregabalin

    Time frame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  13. Part II : accumulation ratio(AUCτ) of Pregabalin

    Time frame: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

Sponsors and collaborators

Lead sponsor

Yungjin Pharm. Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Aug 25, 2017
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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