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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03802526

Enrollment

Registered

2019-01-14

Start date

2019-04-03

Completion date

2019-09-27

Last updated

2019-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Detailed description

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

Interventions

DRUGNVP-1805-R1

1 tablet, multiple oral dosing

DRUGNVP-1805-R2

1 tablet, multiple oral dosing

DRUGNVP-1805-R1 and NVP-1805-R2

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026