- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04780386
Compare the Pharmacokinetics of NVP-1805 and Coadministration of NVP-1805-R1 With NVP-1805-R2 (NVP-1805)
March 1, 2021 updated by: NVP Healthcare
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
The purpose of this study is to compare the pharmacokinetics of NVP-1805 and coadministration of NVP-1805-R1 with NVP-1805-R2.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
pharmacokinetics and safety of NVP-1805 compared to coadministration of NVP-1805-R1 with NVP-1805-R2
Study Type
Interventional
Enrollment (Actual)
58
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
-
-
Nambusunhwan-ro
-
Seoul, Nambusunhwan-ro, Korea, Republic of, 08779
- H plus Yangji 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
- 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
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-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
|
orally, once daily on Period 1 or Period 3 (or Period 2 and Period 4)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics of plasma: AUClast
Time Frame: 0hours - 72hours
|
0hours - 72hours
|
Pharmacokinetics of plasma: Cmax
Time Frame: 0hours - 72hours
|
0hours - 72hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
August 29, 2020
Primary Completion (Actual)
November 2, 2020
Study Completion (Actual)
February 16, 2021
Study Registration Dates
First Submitted
March 1, 2021
First Submitted That Met QC Criteria
March 1, 2021
First Posted (Actual)
March 3, 2021
Study Record Updates
Last Update Posted (Actual)
March 3, 2021
Last Update Submitted That Met QC Criteria
March 1, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- NVP-1805_BE
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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