Status:
COMPLETED
A Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination of HCP1904 and Co-Administration of RLD2001-2 and RLD2006 Tablets in Healthy Subjects.
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Healthy
Eligibility:
All Genders
19-45 years
Phase:
PHASE1
Brief Summary
An Open-Label, Randomized, Single-Dose Crossover Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination of HCP1904 and Co-Administration of RLD2001-2 and RLD2006...
Eligibility Criteria
Inclusion
- Age 19\~45 years in healthy volunteers
- BMI is more than 18.5 kg/m\^2 , no more than 29.9 kg/m\^2
- Subjects who agree to use medically accepted dual contraceptives up to two months after the last administration date of the clinical trial drug and not to provide sperm.
- 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 :
July 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 12 2021
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT05191563
Start Date
July 31 2021
End Date
September 12 2021
Last Update
January 13 2022
Active Locations (1)
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1
Yangji Hospital
Seoul, South Korea