A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.

Healthy Clinical Trial

Official title:

A Randomized, Open-Label, Single-Dose Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05407220
• Other study ID #: HM-CHORUS-102
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 8, 2022
• Est. completion date: July 16, 2022

Study information

• Verified date: May 2022
• Source: Hanmi Pharmaceutical Company Limited
• Contact: Jina Jung, PhD
• Phone: +82)-2-410-9038
• Email: jajung[@]hanmi.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Randomized, Open-Label, Single-Dose Parallel Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HCP1904 in Healthy Male Volunteers.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: July 16, 2022
• Est. primary completion date: July 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Age 19~45 years in healthy male volunteers

2. Weight = 55kg and BMI 18 ~ 30 kg/m^2

3. Subjects who agree to use medically accepted dual contraceptives up to 14 days 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
• HCP1904-3
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, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
Primary	AUC last of Losartan	pharmacokinetic evaluation	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
Primary	AUC inf of Losartan	pharmacokinetic evaluation	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
Primary	Tmax of Losartan	pharmacokinetic evaluation	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
Primary	t1/2 of Losartan	pharmacokinetic evaluation	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
Primary	CL/F of Losartan	pharmacokinetic evaluation	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
Primary	Vd/F of Losartan	pharmacokinetic evaluation	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
Primary	Cmax of EXP3174	pharmacokinetic evaluation	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
Primary	AUC last of EXP3174	pharmacokinetic evaluation	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
Primary	AUC inf of EXP3174	pharmacokinetic evaluation	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
Primary	Tmax of EXP3174	pharmacokinetic evaluation	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
Primary	t1/2 of EXP3174	pharmacokinetic evaluation	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
Primary	CL/F of EXP3174	pharmacokinetic evaluation	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
Primary	Vd/F of EXP3174	pharmacokinetic evaluation	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
Primary	Cmax of Chlorthalidone	pharmacokinetic evaluation	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
Primary	AUC last of Chlorthalidone	pharmacokinetic evaluation	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
Primary	AUC inf of Chlorthalidone	pharmacokinetic evaluation	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
Primary	Tmax of Chlorthalidone	pharmacokinetic evaluation	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
Primary	t1/2 of Chlorthalidone	pharmacokinetic evaluation	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
Primary	CL/F of Chlorthalidone	pharmacokinetic evaluation	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours
Primary	Vd/F of Chlorthalidone	pharmacokinetic evaluation	Day 1, 2, 3, 4, 5, 7 : pre-dose(0 hour)~144hours