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

Phase 1

Completed

• Conditions: Erectile Dysfunction; Prostatic Hyperplasia
• Interventions: Drug: HCP1303; Drug: HGP1201; Drug: HIP1402

• Registration Number: NCT02712411
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

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

Study Timeline

• Study Start: 2015-07
• Primary Completion: 2015-08
• Study Completion: 2015-09
• Status Verified: 2016-02
• Study First Submitted: 2016-02-24
• Study First Submitted QC: 2016-03-14
• Last Update Submitted: 2016-03-14
• Study First Posted: 2016-03-18
• Last Update Posted: 2016-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	HGP1201	T → R T : HCP1303 R : HGP1201 + HIP1402
Sequence 1	HCP1303	T → R T : HCP1303 R : HGP1201 + HIP1402
Sequence 2	HIP1402	R → T T : HCP1303 R : HGP1201 + HIP1402
Sequence 1	HIP1402	T → R T : HCP1303 R : HGP1201 + HIP1402
Sequence 2	HGP1201	R → T T : HCP1303 R : HGP1201 + HIP1402
Sequence 2	HCP1303	R → T T : HCP1303 R : HGP1201 + HIP1402

Primary Outcome Measures

Name	Time	Method
AUClast	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
Cmax	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

Name	Time	Method
tmax	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
t1/2	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
Cl/F	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
Vd/F	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
AUCinf	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

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seodaemun-Gu, Seoul, Korea, Republic of