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

An Open-label, Randomized, 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

NCT04905342

Acronym

Enrollment

Registered

2021-05-27

Start date

2021-08-14

Completion date

2022-01-07

Last updated

2022-02-11

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

orally, once daily on Period 1 and Period 3 (or Period 2 and Period 4) (NVP-1805 80/10/20.8mg)

DRUGNVP-1805-R1and NVP-1805-R2

orally, once daily on Period 1 or Period 3 (or Period 2 and Period 4) (NVP-1805-R1 80mg, NVP-1805-R2 10/20.8mg)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

single-dose, crossover study

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/㎡ 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

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics of plasma: AUClast	0hours - 72hours	period 1,2,3,4
Pharmacokinetics of plasma: Cmax	0hours - 72hours	period 1,2,3,4

Countries

South Korea

Outcome results

None listed

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