Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pharmacokinetic Interaction Between HGP0904, HGP0608 and HGP1405

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: NCT02387554
Recruitment Status : Completed
First Posted : March 13, 2015
Results First Posted : June 12, 2015
Last Update Posted : June 12, 2015
Sponsor:
Collaborator:
Seoul National University Bundang Hospital
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Brief Summary:
The purpose of this study is to investigate the pharmacokinetic interaction and safety between HGP0904, HGP0608 and HGP1405 when administered alone and in combination in healthy male volunteers

Condition or disease Intervention/treatment Phase
Hypertension(HTN) Drug: HGP0904 Drug: HGP0608 Drug: HGP1405 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Randomized, Open-label, 4-way Crossover Single Dose Clinical Trial to Investigate the Pharmacokinetic Interaction Between HGP0904, HGP0608 and HGP1405 When Administered Alone and in Combination in Healthy Male Volunteers
Study Start Date : August 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
Experimental: HGP0904+HGP0608+HGP1405
amlodipine + losartan + chlorthalidone
Drug: HGP0904
Other Name: amlodipine

Drug: HGP0608
Other Name: losartan

Drug: HGP1405
Other Name: chlorthalidone

Active Comparator: HGP0904
amlodipine
Drug: HGP0904
Other Name: amlodipine

Active Comparator: HGP0608
losartan
Drug: HGP0608
Other Name: losartan

Active Comparator: HGP1405
chlorthalidone
Drug: HGP1405
Other Name: chlorthalidone




Primary Outcome Measures :
  1. AUClast [ Time Frame: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr ]
    AUClast(Area under the curve to the last measurable concentration)

  2. Cmax [ Time Frame: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr ]
    Cmax(maxium concentration)


Secondary Outcome Measures :
  1. AUCinf [ Time Frame: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr ]
    AUCinf(Area under the curve to infinity)

  2. Tmax [ Time Frame: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr ]
    Tmax(Time to maximum concentration)

  3. T1/2 [ Time Frame: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr ]
    T1/2(Terminal elimination half-life),

  4. CL/F [ Time Frame: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr ]
    CL/F(Apparent clearance)

  5. Vz/F [ Time Frame: 0, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72, 96, 120, 168hr ]
    Vz/F(Apparent volume of distribution)


Other Outcome Measures:
  1. Number of Paticipants With Adverse Events [ Time Frame: 3 months ]


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:

  • 19~45 years old
  • Healthy men

Exclusion Criteria:

  • Gastroentestinal disease affecting drug absorption

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): NCT02387554


Locations
Layout table for location information
Korea, Republic of
Seoul National University Bundang Hospital
Bundang, Gyeonggi, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Seoul National University Bundang Hospital

Layout table for additonal information
Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT02387554     History of Changes
Other Study ID Numbers: HM-ALCH-101
First Posted: March 13, 2015    Key Record Dates
Results First Posted: June 12, 2015
Last Update Posted: June 12, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases
Losartan
Amlodipine
Chlorthalidone
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors