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

• Sponsor: NVP Healthcare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05023031
• Collaborator: (none)
• Enrollment: 53
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.4
• Patients Per Site Per Month: 15.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: NVP-2102; Drug: NVP-2102-R	Phase 1

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1 Clinical Trial, Open-label, Randomized Study in Healthy Subjects to Evaluate Pharmacokinetic Characteristics and Safety After Oral Administration of NVP-2102 and NVP-2102-R in Healthy Subjects
• Actual Study Start Date: Oct 5, 2021
• Actual Primary Completion Date: Dec 24, 2021
• Actual Study Completion Date: Jan 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: NVP-2102 NVP-2102	Drug: NVP-2102; Tablet formulation for oral administration, single dose of NVP-2102 at Day 1
Active Comparator: NVP-2102-R NVP-2102-R	Drug: NVP-2102-R; Tablet formulation for oral administration, single dose of NVP-2102-R at Day 1

Outcome Measures

Primary Outcome Measures

1. Evaluation of Area under the plasma drug concentration-time curve(AUCt) [0 ~ 72 hours]

   Pharmacokinetics parameter derived from plasma

2. Evaluation of Maximum observed plasma concentration(Cmax) [0 ~ 72 hours]

   Pharmacokinetics parameter derived from plasma

Secondary Outcome Measures

1. Evaluation of Area under the plasma drug concentration-time curve from time 0 to infinity(AUC∞) [0 ~ 72 hours]

   Pharmacokinetics parameter derived from plasma

2. Evaluation of AUCt/AUC∞ [0 ~ 72 hours]

   Pharmacokinetics parameter derived from plasma

3. Evaluation of Time of peak concentration(Tmax) [0 ~ 72 hours]

   Pharmacokinetics parameter derived from plasma

4. Evaluation of Terminal phase of Half-life(t1/2) [0 ~ 72 hours]

   Pharmacokinetics parameter derived from plasma

5. Evaluation of total clearance of the drug from plasma after oral administration(CL/F) [0 ~ 72 hours]

   Pharmacokinetics parameter derived from plasma

6. Evaluation of volume of distribution after non-intravenous administration(Vz/F) [0 ~ 72 hours]

   Pharmacokinetics parameter derived from plasma

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	H Plus Yangji Hospital	Seoul	Nambusunhwan-ro	Korea, Republic of	08779

Sponsors and Collaborators

• NVP Healthcare

Investigators

• Principal Investigator: Jae Woo Kim, H+ Yangji hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NVP Healthcare
• ClinicalTrials.gov Identifier: NCT05023031
• Other Study ID Numbers: NVP-2102_BE
• First Posted: Aug 26, 2021
• Last Update Posted: Jan 19, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 19, 2022