Compare the Pharmacokinetics of NVP-1805 and Coadministration of NVP-1805-R1 With NVP-1805-R2
Overview
The purpose of this study is to compare the pharmacokinetics of NVP-1805 and coadministration of NVP-1805-R1 with NVP-1805-R2.
Full Title of Study: “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”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: November 2, 2020
Detailed Description
pharmacokinetics and safety of NVP-1805 compared to coadministration of NVP-1805-R1 with NVP-1805-R2
Interventions
- Drug: NVP-1805
- orally, once daily on Period 1 and Period 3 (or Period 2 and Period 4)
- Drug: NVP-1805-R1and NVP-1805-R2
- orally, once daily on Period 1 or Period 3 (or Period 2 and Period 4)
Arms, Groups and Cohorts
- Experimental: NVP-1805
- NVP-1805
- Active Comparator: NVP-1805-R1 and NVP-1805-R2
- coadministration of NVP-1805-R1 and NVP-1805-R2
Clinical Trial Outcome Measures
Primary Measures
- Pharmacokinetics of plasma: AUClast
- Time Frame: 0hours – 72hours
- Pharmacokinetics of plasma: Cmax
- Time Frame: 0hours – 72hours
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 19 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- NVP Healthcare
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Jaewoo Kim, M.D., Principal Investigator, H Plus Yangji Hospital
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