Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1603-1 and NVP-1603-2
August 21, 2019 updated by: NVP Healthcare
Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1603-1 and NVP-1603-2 in Healthy Male Volunteers
The purpose of this study is to compare the pharmacokinetics and safety/tolerability between NVP-1603-1 and NVP-1603-2
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
pharmacokinetics and safety/tolerability between NVP-1603-1 and NVP-1603-2
Study Type
Interventional
Phase
- Phase 1
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
Male
Description
Inclusion Criteria:
- Men 19years of age or older at screening test.
- BMI of >18.5kg/㎡ and <27.0kg/㎡ subject, weight more than 50kg.
- Subject has signed and dated informed consent.
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
- Current alcohol abuse.
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-1603-1 (P)
Drug: NVP-1603-1 1capsule, oral dosing |
1capsule, single oral dosing
Other Names:
|
|
Experimental: NVP-1603-2(T)
Drug: NVP-1603-2 1Tablet, oral dosing |
1tablet, single oral dosing
Other Names:
|
|
Experimental: NVP-1603-1and NVP-1603-2 (P+T)
Drug: NVP-1603-1, 1capsule and NVP-1603-2, 1Tablet co-adminstration (oral dosing)
|
1capsule and 1tablet co-administration, oral single dosing
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pharmacokinetic interaction
Time Frame: 0h - 48hrs
|
Area under the curve (AUC)
|
0h - 48hrs
|
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 (Anticipated)
December 1, 2019
Primary Completion (Anticipated)
March 28, 2020
Study Completion (Anticipated)
July 31, 2020
Study Registration Dates
First Submitted
June 30, 2017
First Submitted That Met QC Criteria
July 17, 2017
First Posted (Actual)
July 18, 2017
Study Record Updates
Last Update Posted (Actual)
August 26, 2019
Last Update Submitted That Met QC Criteria
August 21, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- NVP-1603_P1_DDI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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.