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)
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1
Yonsei University Health System, Severance Hospital
Seoul, South Korea