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Pharmacokinetics and Safety of HCP1303 and Co-administration of HGP1201, HIP1402 in Healthy Male Volunteers

Primary Purpose

Erectile Dysfunction, Prostatic Hyperplasia

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HCP1303
HGP1201
HIP1402
Sponsored by
Hanmi Pharmaceutical Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erectile Dysfunction

Eligibility Criteria

19 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Healthy male volunteer, age 20~55 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 thatn 60mmHg or higher than 100mmHg
  6. Subjects who judged ineligible by the investigator.

Sites / Locations

  • Yonsei University Health System, Severance Hospital

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

First Posted
February 24, 2016
Last Updated
March 14, 2016
Sponsor
Hanmi Pharmaceutical Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT02712411
Brief Title
Pharmacokinetics and Safety of HCP1303 and Co-administration of HGP1201, HIP1402 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 in Healthy Male Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
September 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 in healthy male volunteers
Detailed Description
The purpose of this study is to investigate the pharmacokinetic properties and safety after administration of HCP1303 and co-administration of HGP1201, HIP1402 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
30 (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 20~55 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 thatn 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
Facility Information:
Facility Name
Yonsei University Health System, Severance Hospital
City
Seodaemun-Gu
State/Province
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pharmacokinetics and Safety of HCP1303 and Co-administration of HGP1201, HIP1402 in Healthy Male Volunteers

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