Overview
A Study to Evaluate the Pharmacokinetics and Safety Between HCP2202 and Co-administration of Each Component in Healthy Volunteers Under Fed Conditions
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2022-12-18
2022-12-18
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2202 and co-administration of each component in fed condition in healthy volunteers.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Criteria
Inclusion Criteria:- Age 19~54 years in healthy volunteers 18.5 kg/m^2 ≤ BMI < 30 kg/m^2, weight(men) ≥55kg
/ weight(women) ≥45kg
- 90 mmHg ≤ SBP <140 mmHg, 50 mmHg ≤ DBP <90 mmHg
- agrees that the person, spouse, or partner uses appropriate medically recognized
contraception and does not provide sperm or eggs from the date of administration of
the first investigational drug to 7 days after the administration of the last
investigational drug.
- Subjects who voluntarily decides to participate in this clinical trial and agree in
writing to ensure compliance with the clinical trial
Exclusion Criteria:
- 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