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.

Healthy Clinical Trial

Official title:

An Open-Label, Randomized, Single-Dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05191563
• Other study ID #: HM-CHOURS-101
• Status: Completed
• Phase: Phase 1
• Start date: July 31, 2021
• Est. completion date: September 12, 2021

Study information

• Verified date: July 2021
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 Tablets in Healthy Subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 12, 2021
• Est. primary completion date: September 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Age 19~45 years in healthy volunteers

2. BMI is more than 18.5 kg/m^2 , no more than 29.9 kg/m^2

3. 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.

4. 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 Criteria:

1. 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

2. Subjects who judged ineligible by the investigator

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• HCP1904-1
Take it once per period.
• RLD2006
Take it once per period.
• RLD2001-2
Take it once per period.

Locations

Country	Name	City	State
Korea, Republic of	Yangji Hospital	Seoul

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	Cmax of Losartan	Pharmacokinetic evaluation	Day 1, Day 15: pre-dose(0 hour)~48hours
Primary	AUClast of Losartan	Pharmacokinetic evaluation	Day 1, Day 15: pre-dose(0 hour)~48hours
Primary	Cmax of EXP3174	Pharmacokinetic evaluation	Day 1, Day 15: pre-dose(0 hour)~48hours
Primary	AUClast of EXP3174	Pharmacokinetic evaluation	Day 1, Day 15: pre-dose(0 hour)~48hours
Primary	Cmax of Chlorthalidone	Pharmacokinetic evaluation	Day 1, Day 15: pre-dose(0 hour)~144hours
Primary	AUClast of Chlorthalidone	Pharmacokinetic evaluation	Day 1, Day 15:pre-dose(0 hour)~144hours
Secondary	AUC inf, Tmax, T1/2, Cl/F, Vd/F of Losartan	Pharmacokinetic evaluation	Day 1, Day 15: pre-dose(0 hour)~48hours
Secondary	AUC inf, Tmax, T1/2, Cl/F, Vd/F of EXP3174	Pharmacokinetic evaluation	Day 1, Day 15: pre-dose(0 hour)~48hours
Secondary	AUC inf, Tmax, T1/2, Cl/F, Vd/F of Chlorthalidone	Pharmacokinetic evaluation	Day 1, Day 15:pre-dose(0 hour)~144hours