NVP-1805 Compared to Coadministration of NVP-1805-R1 With NVP-1805-R2 in Healthy Adult Volunteers (BE)

An Clinical Trial to Evaluate the Pharmacokinetics and the Safety of NVP-1805 Compared to Coadministration of NVP-1805-R1 With NVP-1805-R2 in Healthy Adult Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05354713

Enrollment

Registered

2022-04-29

Start date

2022-11-05

Completion date

2023-04-27

Last updated

2023-05-06

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

Conditions

Healthy Volunteers

Brief summary

The purpose of this study is to compare the pharmacokinetics of NVP-1805 and coadministration of NVP-1805-R1 with NVP-1805-R2

Detailed description

Evaluate pharmacokinetics and safety of NVP-1805 compared to coadministration of NVP-1805-R1 with NVP-1805-R2

Interventions

DRUGNVP-1805

NVP-1805 (80/10/20.8mg)

DRUGNVP-1805-R1 and NVP-1805-R2

coadministration of NVP-1805-R1(80mg) and NVP-1805-R2(10/20.8mg)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Healthy adult subjects who signed informed consent * BMI of \>18.0 kg/m2 and \<30.0 kg/m2 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

Design outcomes

Primary

Measure	Time frame	Description
NVP-1805's Pharmacokinetics of plasma	0hours - 72hours	AUCt
Pharmacokinetics of plasma	0hours - 72hours	Cmax

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026