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

NVP Healthcare

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: NVP-1805-R1 and NVP-1805-R2; Drug: NVP-1805

Study type: Interventional

Funder types: Industry

Identifiers

NCT05354713

NVP-1805_BE-03

Details and patient eligibility

About

The purpose of this study is to compare the pharmacokinetics of NVP-1805 and coadministration of NVP-1805-R1 with NVP-1805-R2

Full description

Evaluate pharmacokinetics and safety of NVP-1805 compared to coadministration of NVP-1805-R1 with NVP-1805-R2

Enrollment: 58 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult subjects who signed informed consent
• BMI of >18.0 kg/m2 and <30.0 kg/m2 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

NVP-1805

Experimental group

Description:

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

Treatment:

Drug: NVP-1805

NVP-1805-R1 and NVP-1805-R2

Active Comparator group

Description:

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)

Treatment:

Drug: NVP-1805-R1 and NVP-1805-R2