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

Hanmi Pharmaceutical Company Limited36 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Erectile Dysfunction Prostatic Hyperplasia

Interventions

HCP1303DRUG

HGP1201DRUG

HIP1402DRUG

Eligibility

Sex: MALEMin age: 19 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.