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OpenTrials
Completed

NCT Number: NCT04905342

NVP-1805 Compared to Coadministration of NVP-1805-R1 With NVP-1805-R2 in Healthy Adult Volunteers

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

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Key information

Conditions

Healthy Volunteers

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

H Plus Yangji Hospital

Seoul, Nambusunhwan-ro, 08779, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

NVP-1805

Drug

orally, once daily on Period 1 and Period 3 (or Period 2 and Period 4) (NVP-1805 80/10/20.8mg)

NVP-1805-R1and NVP-1805-R2

Drug

orally, once daily on Period 1 or Period 3 (or Period 2 and Period 4) (NVP-1805-R1 80mg, NVP-1805-R2 10/20.8mg)

Primary outcomes

  1. Pharmacokinetics of plasma: AUClast

    Time frame: 0hours - 72hours

    period 1,2,3,4

  2. Pharmacokinetics of plasma: Cmax

    Time frame: 0hours - 72hours

    period 1,2,3,4

Sponsors and collaborators

Lead sponsor

NVP Healthcare

Industry

Registry information

Official study title

An Open-label, Randomized, Evaluate the Pharmacokinetics and the Safety of NVP-1805 Compared to Coadministration of NVP-1805-R1 With NVP-1805-R2 in Healthy Adult Volunteers

Acronym: BE

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
May 27, 2021
Registry last updated
Feb 11, 2022

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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