Evaluation of Pharmacokinetic and Safety of NVP-1705 and NVP-1705-R in Healthy Subjects

NVP Healthcare

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: NVP-1705; Drug: NVP-1705-R

Study type: Interventional

Funder types: Industry

Identifiers

NCT05141110

NVP-1705_BE

Details and patient eligibility

About

The purpose of this study is to compare the pharmacokinetics and safety of NVP-1705 and NVP-1705-R.

Full description

Evaluate the pharmacokinetics and safety of NVP-1705 compared to NVP-1705-R

Enrollment: 50 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy subject, 19 years of age or older
• Subjects who signed informed consent
• Body mass index(BMI) of 18 to 30.0 kg/㎡

Exclusion criteria

• Subject who has clinically significant medical history
• Inadequate subject for the clinical trial by the investigator's decision
• Subjects participated in another clinical trial within 6 months prior to the first administration of investigational product

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

NVP-1705

Experimental group

Description:

Tablet formulation for oral administration, single dose of NVP-1705 at Day 1

Treatment:

Drug: NVP-1705

NVP-1705-R

Active Comparator group

Description:

Tablet formulation for oral administration, single dose of NVP-1705-R at Day 1

Treatment:

Drug: NVP-1705-R