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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02715401

Enrollment

Registered

2016-03-22

Start date

2015-10-31

Completion date

2015-11-30

Last updated

2016-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction, Prostatic Hyperplasia

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

Interventions

DRUGHCP1303

DRUGHGP1201

DRUGHIP1402

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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
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
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
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
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026