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PK and Safety of HCP1303 and Co-administration of HGP1201, HIP1402 Under Fed Condition in Healthy Male Volunteers

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: NCT02715401
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : March 22, 2016
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Brief Summary:
To investigate the pharmacokinetic properties and safety after administration of HCP1303 and co-administration of HGP1201, HIP1402 under Fed Condition in healthy male volunteers

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Prostatic Hyperplasia Drug: HCP1303 Drug: HGP1201 Drug: HIP1402 Phase 1

Detailed Description:
The purpose of this study is to investigate the Pharmacokinetic Properties and Safety after administration of HCP1303 capsule and Co-administration of HGP1201 tablet, HIP1402 capsule under Fed Condition in Healthy Male Volunteers

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Crossover, Single-Dose Study to Compare Pharmacokinetic Properties and Safety After Administration of HCP1303 Capsule and Co-administration of HGP1201 Tablet, HIP1402 Capsule Under Fed Condition in Healthy Male Volunteers
Study Start Date : October 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arm Intervention/treatment
Experimental: Sequence 1

T → R

T : HCP1303 R : HGP1201 + HIP1402

Drug: HCP1303
Drug: HGP1201
Drug: HIP1402
Experimental: Sequence 2

R → T

T : HCP1303 R : HGP1201 + HIP1402

Drug: HCP1303
Drug: HGP1201
Drug: HIP1402



Primary Outcome Measures :
  1. AUClast [ Time Frame: Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose ]
  2. Cmax [ Time Frame: Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose ]

Secondary Outcome Measures :
  1. AUCinf [ Time Frame: Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose ]
  2. tmax [ Time Frame: Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose ]
  3. t1/2 [ Time Frame: Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose ]
  4. Cl/F [ Time Frame: Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose ]
  5. Vd/F [ Time Frame: Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male volunteer, age 19~55 years
  2. The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
  3. Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
  4. Subject who has the ability and willingness to participate the whole period of trial

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 kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
  2. History of relevant drug allergies or clinically significant hypersensitivity reaction.
  3. Glomerular filtration rate is under 60ml/min which is calculated by serum creatinine value.
  4. Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
  5. SBP: lower than 90mmHg or higher than 150mmHg, DBP: lower than 60mmHg or higher than 100mmHg
  6. 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): NCT02715401


Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
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Principal Investigator: Minsu Park, M.D., Ph.D. Yonsei University Health System, Severance Hospital
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Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT02715401    
Other Study ID Numbers: HM-TASU-103
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: March 22, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Erectile Dysfunction
Prostatic Hyperplasia
Hyperplasia
Pathologic Processes
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
Prostatic Diseases