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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2015-11-30

Brief Summary

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

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Detailed Description

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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

Conditions

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Erectile Dysfunction Prostatic Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence 1

T → R

T : HCP1303 R : HGP1201 + HIP1402

Group Type EXPERIMENTAL

HCP1303

Intervention Type DRUG

HGP1201

Intervention Type DRUG

HIP1402

Intervention Type DRUG

Sequence 2

R → T

T : HCP1303 R : HGP1201 + HIP1402

Group Type EXPERIMENTAL

HCP1303

Intervention Type DRUG

HGP1201

Intervention Type DRUG

HIP1402

Intervention Type DRUG

Interventions

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HCP1303

Intervention Type DRUG

HGP1201

Intervention Type DRUG

HIP1402

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes