MedTrace Logo

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

NCT04018378 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-07-12

No results posted yet for this study

Summary

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

Conditions

  • Healthy

Interventions

DRUG

varenicline tartrate 1mg (HGP1604, R) - varenicline oxalate 1mg (HIP1502, T), RT

varenicline tartrate 1mg (HGP1604) was used as a reference drug and varenicline oxalate 1mg (HIP1502) was used as a test drug.

DRUG

varenicline oxalate 1mg (HIP1502, T) - varenicline tartrate 1mg (HGP1604, R), TR

varenicline tartrate 1mg (HGP1604) was used as a reference drug and varenicline oxalate 1mg (HIP1502) was used as a test drug.

Sponsors & Collaborators

  • Korea University Anam Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-06
Primary Completion
2017-05-15
Completion
2018-09-17

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04018378 on ClinicalTrials.gov