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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03802526
Recruitment Status : Completed
First Posted : January 14, 2019
Last Update Posted : November 29, 2019
Sponsor:
Information provided by (Responsible Party):
Navipharm Corporation

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

Condition or disease Intervention/treatment Phase
Healthy Drug: NVP-1805-R1 Drug: NVP-1805-R2 Drug: NVP-1805-R1 and NVP-1805-R2 Phase 1

Detailed Description:
pharmacokinetics and safety/tolerability between NVP-1805-R1 and NVP-1805-R2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1805-R1 and NVP-1805-R2 in Healthy Volunteers
Actual Study Start Date : April 3, 2019
Actual Primary Completion Date : July 4, 2019
Actual Study Completion Date : September 27, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: NVP-1805-R1

Drug: NVP-1805-R1

1 tablet, oral dosing

Drug: NVP-1805-R1
1 tablet, multiple oral dosing
Other Name: NVP-1805-R1(M)

Experimental: NVP-1805-R2

Drug: NVP-1805-R2

1 tablet, oral dosing

Drug: NVP-1805-R2
1 tablet, multiple oral dosing
Other Name: NVP-1805-R2(C)

Experimental: NVP-1805-R1 and NVP-1805-R2
Drug: NVP-1801-R1 1 tablet and NVP-1801-R2 1 tablet co-administration(oral dosing)
Drug: NVP-1805-R1 and NVP-1805-R2
NVP-1805-R1,1 tablet and NVP-1805-R2, 1 tablet, co-administration, multiple oral dosing
Other Name: NVP-1805-R1(M) and NVP-1805-R2(C)




Primary Outcome Measures :
  1. Pharmacokinetic interaction [ Time Frame: 0hours - 48hours ]
    Area under the curve (AUC)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802526


Locations
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Korea, Republic of
Navipharm
Suwon-si, Gyeonggi-do, Korea, Republic of, 16209
Sponsors and Collaborators
Navipharm Corporation
Investigators
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Principal Investigator: Dong Sung Shin, M.D. Gachon University Gil Medical Center
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Responsible Party: Navipharm Corporation
ClinicalTrials.gov Identifier: NCT03802526    
Other Study ID Numbers: NVP-1805_DDI
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: November 29, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No