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Completed

NCT Number: NCT03802526

Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1805-R1 and NVP-1805-R2

The purpose of this study is to compare the pharmacokinetics and safety/tolerability between NVP-1805-R1 and NVP-1805-R2

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Key information

Conditions

Healthy

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Navipharm

Suwon, Gyeonggi-do, 16209, South Korea

About this study

pharmacokinetics and safety/tolerability between NVP-1805-R1 and NVP-1805-R2

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female adults aged 19-45 years.
  • BMI of >18.5 kg/㎡ and <27.0 kg/㎡ subject, weight more than 50kg.
  • Voluntarily provided a witten consent to participate in this clinical study.

Exclusion criteria

  • Treatment with an investigational product (Phase I study or Biological study) within 3month preceeding the first dose of study medication.
  • History of (or presence) study medication absortion, distribution, metabolism(e.g., liver/ductal, kidney, cardio-vascular, endocrine, respiratory, GI, hematology, oncology, CNS, musculo-skeletal) or related past medical/surgery history
  • Pregnant or lactating women.

Treatment and study plan

NVP-1805-R1

Drug

1 tablet, multiple oral dosing

Other names: NVP-1805-R1(M)

NVP-1805-R2

Drug

1 tablet, multiple oral dosing

Other names: NVP-1805-R2(C)

NVP-1805-R1 and NVP-1805-R2

Drug

NVP-1805-R1,1 tablet and NVP-1805-R2, 1 tablet, co-administration, multiple oral dosing

Other names: NVP-1805-R1(M) and NVP-1805-R2(C)

Primary outcomes

  1. Pharmacokinetic interaction

    Time frame: 0hours - 48hours

    Area under the curve (AUC)

Sponsors and collaborators

Lead sponsor

NVP Healthcare

Industry

Registry information

Official study title

Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1805-R1 and NVP-1805-R2 in Healthy Volunteers

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 14, 2019
Registry last updated
Nov 29, 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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