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

NVP Healthcare

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: NVP-1203

Study type: Interventional

Funder types: Industry

Identifiers

NCT02289404

NVP-1203_FE

Details and patient eligibility

About

The purpose of this study is to evaluate food effect on the pharmacokinetics of NVP-1203

Full 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

Enrollment: 39 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

NVP-1203(fed then fasting)

Experimental group

Description:

Subjects will receive a oral dose of NVP-1203 under fed conditions in period 1, then subjects will receive a oral dose of NVP-1203 under fasting conditions in period 2

Treatment:

Drug: NVP-1203

Drug: NVP-1203

NVP-1203(fasting then fed)

Experimental group

Description:

Subjects will receive a oral dose of NVP-1203 under fasting conditions in period 1, then subjects will receive a oral dose of NVP-1203 under fed conditions in period 2

Treatment:

Drug: NVP-1203

Drug: NVP-1203