Back to resultsPK and Safety of HCP1303 and Co-administration of HGP1201, HIP1402 Under Fed Condition in Healthy Male Volunteers
Primary Purpose
Erectile Dysfunction, Prostatic Hyperplasia
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
HCP1303
HGP1201
HIP1402
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction
Eligibility Criteria
Inclusion Criteria:
- Healthy male volunteer, age 19~55 years
- The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
- Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
- Subject who has the ability and willingness to participate the whole period of trial
Exclusion Criteria:
- 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.
- History of relevant drug allergies or clinically significant hypersensitivity reaction.
- Glomerular filtration rate is under 60ml/min which is calculated by serum creatinine value.
- Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
- SBP: lower than 90mmHg or higher than 150mmHg, DBP: lower than 60mmHg or higher than 100mmHg
- Subjects who judged ineligible by the investigator.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sequence 1
Sequence 2
Arm Description
T → R T : HCP1303 R : HGP1201 + HIP1402
R → T T : HCP1303 R : HGP1201 + HIP1402
Outcomes
Primary Outcome Measures
AUClast
Cmax
Secondary Outcome Measures
AUCinf
tmax
t1/2
Cl/F
Vd/F
Full Information
NCT ID
NCT02715401
First Posted
January 29, 2016
Last Updated
March 21, 2016
Sponsor
Hanmi Pharmaceutical Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT02715401
Brief Title
PK and Safety of HCP1303 and Co-administration of HGP1201, HIP1402 Under Fed Condition in Healthy Male Volunteers
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 Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction, Prostatic Hyperplasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence 1
Arm Type
Experimental
Arm Description
T → R
T : HCP1303 R : HGP1201 + HIP1402
Arm Title
Sequence 2
Arm Type
Experimental
Arm Description
R → T
T : HCP1303 R : HGP1201 + HIP1402
Intervention Type
Drug
Intervention Name(s)
HCP1303
Intervention Type
Drug
Intervention Name(s)
HGP1201
Intervention Type
Drug
Intervention Name(s)
HIP1402
Primary Outcome Measure Information:
Title
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
Title
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 Measure Information:
Title
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
Title
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
Title
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
Title
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
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male volunteer, age 19~55 years
The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
Subject who has the ability and willingness to participate the whole period of trial
Exclusion Criteria:
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.
History of relevant drug allergies or clinically significant hypersensitivity reaction.
Glomerular filtration rate is under 60ml/min which is calculated by serum creatinine value.
Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
SBP: lower than 90mmHg or higher than 150mmHg, DBP: lower than 60mmHg or higher than 100mmHg
Subjects who judged ineligible by the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minsu Park, M.D., Ph.D.
Organizational Affiliation
Yonsei University Health System, Severance Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PK and Safety of HCP1303 and Co-administration of HGP1201, HIP1402 Under Fed Condition in Healthy Male Volunteers
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