Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04322266
Recruitment Status : Completed
First Posted : March 26, 2020
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Brief 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

Condition or disease Intervention/treatment Phase
Healthy Drug: HCP1701 Drug: HCP1306 Drug: HGP0904 Drug: HGP0608 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 21, 2018
Actual Primary Completion Date : February 13, 2019
Actual Study Completion Date : February 13, 2019

Arm Intervention/treatment
Experimental: Sequence 1 (Reference-Test)
Period1: HCP1306+HGP0904+HGP0608, Period 2: HCP1701
Drug: HCP1701
Ezetimibe / Rosuvastatin / Amlodipine / Losartan potassium

Drug: HCP1306
Ezetimibe /Rosuvastatin

Drug: HGP0904
Amlodipine

Drug: HGP0608
Losartan potassium

Experimental: Sequence 2 (Test-Reference)
Period1: HCP1701, Period 2: HCP1306+HGP0904+HGP0608
Drug: HCP1701
Ezetimibe / Rosuvastatin / Amlodipine / Losartan potassium

Drug: HCP1306
Ezetimibe /Rosuvastatin

Drug: HGP0904
Amlodipine

Drug: HGP0608
Losartan potassium




Primary Outcome Measures :
  1. Cmax of Amlodipine [ Time Frame: 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 ]
    Pharmacokinetic evaluation

  2. AUClast of Amlodipine [ Time Frame: 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 ]
    Pharmacokinetic evaluation

  3. Cmax of Losartan [ Time Frame: 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 ]
    Pharmacokinetic evaluation

  4. AUClast of Losartan [ Time Frame: 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 ]
    Pharmacokinetic evaluation

  5. Cmax of Rosuvastatin [ Time Frame: 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 ]
    Pharmacokinetic evaluation

  6. AUClast of Rosuvastatin [ Time Frame: 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 ]
    Pharmacokinetic evaluation

  7. Cmax of Free Ezetimibe [ Time Frame: 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 ]
    Pharmacokinetic evaluation

  8. AUClast of Free Ezetimibe [ Time Frame: 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 ]
    Pharmacokinetic evaluation

  9. Cmax of EXP3174 [ Time Frame: 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 ]
    Pharmacokinetic evaluation

  10. AUClast of EXP3174 [ Time Frame: 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 ]
    Pharmacokinetic evaluation


Secondary Outcome Measures :
  1. Cmax of Total Ezetimibe [ Time Frame: 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 ]
    Pharmacokinetic evaluation

  2. AUClast of Total Ezetimibe [ Time Frame: 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 ]
    Pharmacokinetic evaluation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04322266


Locations
Layout table for location information
Korea, Republic of
Korea University Hospital (Anam)
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Layout table for additonal information
Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT04322266    
Other Study ID Numbers: HM-AMOS-102
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No