Status:

COMPLETED

A Study to Evaluate the Pharmacokinetics and Safety of HIP1701 in Healthy Subjects

Lead Sponsor:

Hanmi Pharmaceutical Company Limited

Conditions:

Health, Subjective

Eligibility:

All Genders

19-55 years

Phase:

PHASE1

Brief Summary

An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics and safety of HIP1701 in healthy subjects.

Eligibility Criteria

Inclusion

  • Age 19\~55 years in healthy volunteers
  • BMI is more than 18.5 kg/m\^2 , no more than 24.9 kg/m\^2
  • Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion

  • Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
  • Subjects who judged ineligible by the investigator

Key Trial Info

Start Date :

October 23 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 27 2018

Estimated Enrollment :

31 Patients enrolled

Trial Details

Trial ID

NCT04087525

Start Date

October 23 2018

End Date

November 27 2018

Last Update

September 12 2019

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Yonsei University Health System, Severance Hospital

Seoul, South Korea