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NCT06346184 Clinical Trial

A Study to Evaluate the Pharmacokinetics and Safety Between HCP2303 and Co-administration of Each Component in Healthy Volunteers

Healthy Clinical Trial

Official title:
A Randomized, Open Label, Single Dose, Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety After Administration of a Fixed-dose Combination Drug of HCP2303 and Co-administration of RLD2302 and RLD2102 in Healthy Volunteers Under Fasting Conditions

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06346184
Other study ID # HM-EMMA-101
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date April 30, 2024
Est. completion date June 8, 2024

Study information
Verified date March 2024
Source Hanmi Pharmaceutical Company Limited
Contact NaYoung Kim
Phone 02-410-9165
Email skyko7@hanmi.co.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2303 and co-administration of each component in fasting condition in healthy volunteers.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 36
Est. completion date June 8, 2024
Est. primary completion date June 8, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 54 Years
Eligibility 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 = sitSBP <140 mmHg, 50 mmHg = sitDBP <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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• HCP2303
Take 1 tablet once per period
• RLD2302
Take 1 tablet once per period
• RLD2102
Take 1 tablet once per period

Locations
Country Name City State
Korea, Republic of Jeonbuk University Hospital Jeonju Jeollabuk-do

Sponsors (1)
Lead Sponsor Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary AUCt Pharmacokinetic evaluation 0~48 hours
Primary Cmax Pharmacokinetic evaluation 0~48 hours
Secondary AUCinf Pharmacokinetic evaluation 0~48 hours
Secondary Tmax Pharmacokinetic evaluation 0~48 hours
Secondary t1/2 Pharmacokinetic evaluation 0~48 hours
Secondary CL/F Pharmacokinetic evaluation 0~48 hours
Secondary Vd/F Pharmacokinetic evaluation 0~48 hours
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