Clinical Trials Logo
  1. Home
  2. Healthy
  3. NCT03220399
  4. Details
NCT03220399 Clinical Trial

Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1603-1 and NVP-1603-2

Healthy Clinical Trial

Official title:
Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1603-1 and NVP-1603-2 in Healthy Male Volunteers

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03220399
Other study ID # NVP-1603_P1_DDI
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date December 1, 2019
Est. completion date July 31, 2020

Study information
Verified date August 2019
Source Navipharm Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the pharmacokinetics and safety/tolerability between NVP-1603-1 and NVP-1603-2

Description:

pharmacokinetics and safety/tolerability between NVP-1603-1 and NVP-1603-2

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date July 31, 2020
Est. primary completion date March 28, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years and older
Eligibility Inclusion Criteria:

- Men 19years of age or older at screening test.

- BMI of >18.5kg/? and <27.0kg/? subject, weight more than 50kg.

- Subject has signed and dated informed consent.

Exclusion Criteria:

- Treatment with an investigational product (Phase I study or Biological study) within 3month preceeding the first dose of study medication.

- History of (or presence) study medication absortion, distribution, metabolism(e.g., liver/ductal, kidney, cardio-vascular, endocrine, respiratory, GI, hematology, oncology, CNS, musculo-skeletal) or related past medical/surgery history

- Current alcohol abuse.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• NVP-1603-1 (P)
1capsule, single oral dosing
• NVP-1603-2 (T)
1tablet, single oral dosing
• NVP-1603-1 and NVP-1603-2 (P+T)
1capsule and 1tablet co-administration, oral single dosing

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Navipharm Corporation

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetic interaction Area under the curve (AUC) 0h - 48hrs
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1