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NCT04322266 Clinical Trial

A Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination and Co-Administration of HGP0904, HGP0608 and HCP1306 Tablets in Healthy Male Subjects.

Healthy Clinical Trial

Official title:
An Open-Label, Randomized, Single-Dose Crossover Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination and Co-Administration of HGP0904, HGP0608 and HCP1306 Tablets in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04322266
Other study ID # HM-AMOS-102
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 21, 2018
Est. completion date February 13, 2019

Study information
Verified date March 2020
Source Hanmi Pharmaceutical Company Limited
Contact n/a
Is FDA regulated No
Health authority
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 and Co-Administration of HGP0904, HGP0608 and HCP1306 Tablets in Healthy Male Subjects

Recruitment information / eligibility
Status Completed
Enrollment 61
Est. completion date February 13, 2019
Est. primary completion date February 13, 2019
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 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• HCP1701
Ezetimibe / Rosuvastatin / Amlodipine / Losartan potassium
• HCP1306
Ezetimibe /Rosuvastatin
• HGP0904
Amlodipine
• HGP0608
Losartan potassium

Locations
Country Name City State
Korea, Republic of Korea University Hospital (Anam) 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 Amlodipine Pharmacokinetic evaluation Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 144hours
Primary AUClast of Amlodipine Pharmacokinetic evaluation Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 144hours
Primary Cmax of Losartan Pharmacokinetic evaluation Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours
Primary AUClast of Losartan Pharmacokinetic evaluation Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours
Primary Cmax of Rosuvastatin Pharmacokinetic evaluation Day 1,Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours
Primary AUClast of Rosuvastatin Pharmacokinetic evaluation Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours
Primary Cmax of Free Ezetimibe Pharmacokinetic evaluation Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours
Primary AUClast of Free Ezetimibe Pharmacokinetic evaluation Day 1, Day15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours
Primary Cmax of EXP3174 Pharmacokinetic evaluation Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours
Primary AUClast of EXP3174 Pharmacokinetic evaluation Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48 hours
Secondary Cmax of Total Ezetimibe Pharmacokinetic evaluation Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours
Secondary AUClast of Total Ezetimibe Pharmacokinetic evaluation Day 1, Day 15: pre-dose(0 hour), 0.33, 0.67, 1, 1.33, 1.67, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 hours
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