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NCT05141110 | Completed | Healthy Subjects

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

NVP Healthcare

Brief Summary:

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

Condition or disease

Healthy Subjects

Intervention/treatment

NVP-1705

NVP-1705-R

Phase

Phase 1

Detailed Description:

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

Study Type : Interventional
Estimated Enrollment : 50 participants
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 of NVP-1705 and NVP-1705-R in Healthy Subjects
Actual Study Start Date : December 29, 2021
Estimated Primary Completion Date : April 27, 2022
Estimated Study Completion Date : June 29, 2022
Arm Intervention/treatment

Experimental: NVP-1705

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

Drug: NVP-1705

Active Comparator: NVP-1705-R

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

Drug: NVP-1705-R
Ages Eligible for Study: 19 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
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
Evaluation of Pharmacokinetic and Safety of NVP-1705 and NVP-1705-R in Healthy Subjects

Location Details

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Korea, Republic of, Nambusunhwan-ro

H Plus Yangji Hospital

Seoul, Nambusunhwan-ro, Korea, Republic of, 08779