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

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: NCT04780386
Recruitment Status : Completed
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Navipharm Corporation

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

Condition or disease Intervention/treatment Phase
Healthy Drug: NVP-1805 Drug: NVP-1805-R1and NVP-1805-R2 Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 29, 2020
Actual Primary Completion Date : November 2, 2020
Actual Study Completion Date : February 16, 2021

Arm Intervention/treatment
Experimental: NVP-1805
NVP-1805
Drug: NVP-1805
orally, once daily on Period 1 and Period 3 (or Period 2 and Period 4)

Active Comparator: NVP-1805-R1 and NVP-1805-R2
coadministration of NVP-1805-R1 and NVP-1805-R2
Drug: NVP-1805-R1and NVP-1805-R2
orally, once daily on Period 1 or Period 3 (or Period 2 and Period 4)




Primary Outcome Measures :
  1. Pharmacokinetics of plasma: AUClast [ Time Frame: 0hours - 72hours ]
  2. Pharmacokinetics of plasma: Cmax [ Time Frame: 0hours - 72hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT04780386


Locations
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Korea, Republic of
H Plus Yangji Hospital
Seoul, Nambusunhwan-ro, Korea, Republic of, 08779
Sponsors and Collaborators
Navipharm Corporation
Investigators
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Principal Investigator: Jaewoo Kim, M.D. H Plus Yangji Hospital
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Responsible Party: Navipharm Corporation
ClinicalTrials.gov Identifier: NCT04780386    
Other Study ID Numbers: NVP-1805_BE
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: March 2021

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