Clinical Trials Directory

Trials / Completed

CompletedNCT04018378

A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HIP1502

An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HIP1502 in Healthy Male Subjects

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Korea University Anam Hospital · Academic / Other
Sex
All
Age
20 Years – 45 Years
Healthy volunteers
Accepted

Summary

The clinical trial aims to assess the pharmacokinetics, safety and tolerability of HIP1502 in healthy male subjects.

Conditions

Interventions

TypeNameDescription
DRUGvarenicline tartrate 1mg (HGP1604, R) - varenicline oxalate 1mg (HIP1502, T), RTvarenicline tartrate 1mg (HGP1604) was used as a reference drug and varenicline oxalate 1mg (HIP1502) was used as a test drug.
DRUGvarenicline oxalate 1mg (HIP1502, T) - varenicline tartrate 1mg (HGP1604, R), TRvarenicline tartrate 1mg (HGP1604) was used as a reference drug and varenicline oxalate 1mg (HIP1502) was used as a test drug.

Timeline

Start date
2017-01-06
Primary completion
2017-05-15
Completion
2018-09-17
First posted
2019-07-12
Last updated
2019-07-12

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT04018378. Inclusion in this directory is not an endorsement.