Compare the Pharmacokinetics of NVP-1805 and Coadministration of NVP-1805-R1 With NVP-1805-R2

Overview

The purpose of this study is to compare the pharmacokinetics of NVP-1805 and coadministration of NVP-1805-R1 with NVP-1805-R2.

Full Title of Study: “A Clinical Trial to Compare the Pharmacokinetics and Safety of NVP-1805 and Coadministration of NVP-1805-R1 With NVP-1805-R2 in Healthy Male Volunteers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2, 2020

Detailed Description

pharmacokinetics and safety of NVP-1805 compared to coadministration of NVP-1805-R1 with NVP-1805-R2

Interventions

  • Drug: NVP-1805
    • orally, once daily on Period 1 and Period 3 (or Period 2 and Period 4)
  • Drug: NVP-1805-R1and NVP-1805-R2
    • orally, once daily on Period 1 or Period 3 (or Period 2 and Period 4)

Arms, Groups and Cohorts

  • Experimental: NVP-1805
    • NVP-1805
  • Active Comparator: NVP-1805-R1 and NVP-1805-R2
    • coadministration of NVP-1805-R1 and NVP-1805-R2

Clinical Trial Outcome Measures

Primary Measures

  • Pharmacokinetics of plasma: AUClast
    • Time Frame: 0hours – 72hours
  • Pharmacokinetics of plasma: Cmax
    • Time Frame: 0hours – 72hours

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy adult subjects who signed informed consent – BMI of >18.0 kg/㎡ and <30.0 kg/㎡ subject, weight more than 50kg(45 kg or more for woman) Exclusion Criteria:

  • Subjects participated in another clinical trial within 6 months prior to administration of the study drug – Inadequate subject for the clinical trial by the investigator's decision – Subjects participated in another clinical trial within 6 months prior to administration of the study drug

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • NVP Healthcare
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jaewoo Kim, M.D., Principal Investigator, H Plus Yangji Hospital

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