NCT03802526

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Apr 2019

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

April 3, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2019

Completed
Last Updated

November 29, 2019

Status Verified

November 1, 2019

Enrollment Period

3 months

First QC Date

January 10, 2019

Last Update Submit

November 26, 2019

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic interaction

    Area under the curve (AUC)

    0hours - 48hours

Study Arms (3)

NVP-1805-R1

EXPERIMENTAL

Drug: NVP-1805-R1 1 tablet, oral dosing

Drug: NVP-1805-R1

NVP-1805-R2

EXPERIMENTAL

Drug: NVP-1805-R2 1 tablet, oral dosing

Drug: NVP-1805-R2

NVP-1805-R1 and NVP-1805-R2

EXPERIMENTAL

Drug: NVP-1801-R1 1 tablet and NVP-1801-R2 1 tablet co-administration(oral dosing)

Drug: NVP-1805-R1 and NVP-1805-R2

Interventions

NVP-1805-R1DRUG

1 tablet, multiple oral dosing

Also known as: NVP-1805-R1(M)
NVP-1805-R1
NVP-1805-R2DRUG

1 tablet, multiple oral dosing

Also known as: NVP-1805-R2(C)
NVP-1805-R2
NVP-1805-R1 and NVP-1805-R2DRUG

NVP-1805-R1,1 tablet and NVP-1805-R2, 1 tablet, co-administration, multiple oral dosing

Also known as: NVP-1805-R1(M) and NVP-1805-R2(C)
NVP-1805-R1 and NVP-1805-R2

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Navipharm

Suwon, Gyeonggi-do, 16209, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 33326064DERIVED

Study Officials

  • Dong Sung Shin, M.D.

    Gachon University Gil Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2019

First Posted

January 14, 2019

Study Start

April 3, 2019

Primary Completion

July 4, 2019

Study Completion

September 27, 2019

Last Updated

November 29, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)