Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1603-1 and NVP-1603-2

Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1603-1 and NVP-1603-2 in Healthy Male Volunteers

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03220399

Enrollment

Registered

2017-07-18

Start date

2019-12-01

Completion date

2020-07-31

Last updated

2019-08-26

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-1603-1 and NVP-1603-2

Detailed description

pharmacokinetics and safety/tolerability between NVP-1603-1 and NVP-1603-2

Interventions

DRUGNVP-1603-1 (P)

1capsule, single oral dosing

DRUGNVP-1603-2 (T)

1tablet, single oral dosing

DRUGNVP-1603-1 and NVP-1603-2 (P+T)

1capsule and 1tablet co-administration, oral single dosing

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Men 19years of age or older at screening test. * BMI of \>18.5kg/㎡ and \<27.0kg/㎡ subject, weight more than 50kg. * Subject has signed and dated informed consent.

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 * Current alcohol abuse.

Design outcomes

Primary

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

Outcome results

None listed

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