Evaluation of Pharmacokinetic and Safety of NVP-2102 and NVP-2102-R in Healthy Subjects

NVP Healthcare

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: NVP-2102; Drug: NVP-2102-R

Study type: Interventional

Funder types: Industry

Identifiers

NCT05023031

NVP-2102_BE

Details and patient eligibility

About

The purpose of this study is to compare the pharmacokinetics and safety of NVP-2102 and NVP-2102-R.

Full description

Evaluate the pharmacokinetics and safety of NVP-2102 compared to NVP-2102-R

Enrollment: 53 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)

---

53 participants in 2 patient groups

NVP-2102

Experimental group

Description:

NVP-2102

Treatment:

Drug: NVP-2102

NVP-2102-R

Active Comparator group

Description:

NVP-2102-R

Treatment:

Drug: NVP-2102-R