Pharmacokinetic Interaction and Safety Between NVP-1203-R1 and NVP-1203-R2 (Navipharm)

August 28, 2020 updated by: NVP Healthcare

A Phase I Clinical Trial to Evaluate the Pharmacokinetic Interaction and Safety Between NVP-1203-R1 and NVP-1203-R2 in Healthy Adult Subjects

The purpose of this study is to compare the pharmacokinetics and safety between NVP-1203-R1 and NVP-1203-R2

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

pharmacokinetics and safety between NVP-1203-R1 and NVP-1203-R2

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Dongdeok-ro
      • Daegu, Dongdeok-ro, Korea, Republic of, 700-721
        • Kyungpook National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy adult subjects who signed informed consent

Exclusion Criteria:

  • Subjects has a history of allergy reaction of study drug ingredient
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NVP-1203-R1

Drug: NVP-1203-R1

1 tablet, oral dosing
Drug: NVP-1203-R1
1 tablet, Single oral dosing
Other Names:
  • NVP-1203-R1(A)
Experimental: NVP-1203-R2

Drug: NVP-1203-R2

1 tablet, oral dosing
Drug: NVP-1203-R2
1 tablet, Single oral dosing
Other Names:
  • NVP-1203-R2(E)
Experimental: NVP-1203-R1 and NVP-1203-R2
Drug: NVP-1203-R1 1 tablet and NVP-1203-R2 1 tablet co-administration(oral dosing)
Drug: NVP-1203-R1 and NVP-1203-R2
NVP-1203-R1,1 tablet and NVP-1203-R2, 1 tablet, co-administration, single oral dosing
Other Names:
  • NVP-1203-R1(A) and NVP-1203-R2(E)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic interaction
Time Frame: 0hours - 24hours
Area under the curve (AUC)
0hours - 24hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NVP Healthcare

Investigators

  • Principal Investigator: Yoon Y Ran, M.D., Kyungpook National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Actual)

May 17, 2020

Study Completion (Actual)

May 29, 2020

Study Registration Dates

First Submitted

November 26, 2019

First Submitted That Met QC Criteria

November 26, 2019

First Posted (Actual)

November 29, 2019

Study Record Updates

Last Update Posted (Actual)

September 1, 2020

Last Update Submitted That Met QC Criteria

August 28, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • NVP-1203_DDI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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