Pharmacokinetic Interaction and Safety Between NVP-1203-R1 and NVP-1203-R2

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: NVP-1203-R1; Drug: NVP-1203-R2; Drug: NVP-1203-R1 and NVP-1203-R2

• Registration Number: NCT04181437
• Lead Sponsor: NVP Healthcare

Brief Summary

The purpose of this study is to compare the pharmacokinetics and safety between NVP-1203-R1 and NVP-1203-R2

Detailed Description

pharmacokinetics and safety between NVP-1203-R1 and NVP-1203-R2

Study Timeline

• Study First Submitted: 2019-11-26
• Study First Submitted QC: 2019-11-26
• Study First Posted: 2019-11-29
• Study Start: 2020-05-01
• Primary Completion: 2020-05-17
• Study Completion: 2020-05-29
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-28
• Last Update Posted: 2020-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 6 months prior to administration of the study drug
• Inadequate subject for the clinical trial by the investigator's decision

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NVP-1203-R1	NVP-1203-R1	Drug: NVP-1203-R1 1 tablet, oral dosing
NVP-1203-R2	NVP-1203-R2	Drug: NVP-1203-R2 1 tablet, oral dosing
NVP-1203-R1 and NVP-1203-R2	NVP-1203-R1 and NVP-1203-R2	Drug: NVP-1203-R1 1 tablet and NVP-1203-R2 1 tablet co-administration(oral dosing)

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic interaction	0hours - 24hours	Area under the curve (AUC)

Trial Locations

Locations (1)

Kyungpook National University Hospital; 🇰🇷 Daegu, Dongdeok-ro, Korea, Republic of