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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: NVP-1805-R1; Drug: NVP-1805-R2; Drug: NVP-1805-R1 and NVP-1805-R2

Detailed Description

pharmacokinetics and safety/tolerability between NVP-1805-R1 and NVP-1805-R2

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Suwon-si, Gyeonggi-do, Korea, Republic of, 16209
      • Navipharm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: NVP-1805-R1(M) and NVP-1805-R2(C)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic interaction	Area under the curve (AUC)	0hours - 48hours

Collaborators and Investigators

• Sponsor: NVP Healthcare
• Investigators: Principal Investigator: Dong Sung Shin, M.D., Gachon University Gil Medical Center

Publications and helpful links

General Publications

• Kim CH, Kang SI, Shin D. Pharmacokinetic Interaction Between Telmisartan and Rosuvastatin/Ezetimibe After Multiple Oral Administration in Healthy Subjects. Adv Ther. 2021 Feb;38(2):1094-1105. doi: 10.1007/s12325-020-01592-8. Epub 2020 Dec 16.

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2019
• Primary Completion (Actual): July 4, 2019
• Study Completion (Actual): September 27, 2019

Study Registration Dates

• First Submitted: January 10, 2019
• First Submitted That Met QC Criteria: January 10, 2019
• First Posted (Actual): January 14, 2019

Study Record Updates

• Last Update Posted (Actual): November 29, 2019
• Last Update Submitted That Met QC Criteria: November 26, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: NVP-1805_DDI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No