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
• Status: Not yet recruiting
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Healthy

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