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A Study to Evaluate the Food Effect on the Pharmacokinetics of NVP-1203

Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of NVP-1203 in Healthy Adult Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02289404
Acronym
NVP-1203
Enrollment
39
Registered
2014-11-13
Start date
2019-01-18
Completion date
2019-02-28
Last updated
2019-03-08

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 evaluate food effect on the pharmacokinetics of NVP-1203

Detailed description

This study is designed as randomized, open-label, crossover assignment for evaluate the food effect on the pharmacokinetics of NVP-1203 in healthy adult subjects

Interventions

Oral

Sponsors

NVP Healthcare
Lead SponsorINDUSTRY

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

Exclusion criteria

* Subjects has a history of allergy reaction of study drug ingredient * Subjects participated in another clinical trial within 3 months prior to administration of the study drug * Inadequate subject for the clinical trial by the investigator's decision

Design outcomes

Primary

MeasureTime frameDescription
Pharmacokinetics : Cmax0-24 hoursMaximum plasma concentration
Pharmacokinetics : AUCt0-24 hoursArea under the concentration-time curve

Secondary

MeasureTime frameDescription
Pharmacokinetics : AUCinf0-24 hoursAUC extrapolated to infinity
Pharmacokinetics : Tmax0-24 hoursTime to reach the Cmax
Pharmacokinetics : t1/20-24 hoursTerminal elimination half-life

Countries

South Korea

Outcome results

None listed

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