Investigating the Pharmacokinetic Characteristics of HIP1402 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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2015-10-31

Brief Summary

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To investigate the PK charateristics and the effect of food on the PK in healthy male volunteers who receive HIP1402 capsule in fed versus fasted condition

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Detailed Description

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A randomized, open-label, single dose, three-way crossover clinical trial to investigate the pharmacokinetics incorporating a comparison of fed/fasted pharmacokinetics of HIP1402 in healthy male volunteers

Conditions

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Healthy

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

High fat diet+HGP0412 → High fat diet+HIP1402 → fasted state+HIP1402

Group Type EXPERIMENTAL

HIP1402

Intervention Type DRUG

Tamsulosin HCl 0.4mg

HGP0412

Intervention Type DRUG

Tamsulosin HCl 0.2mg

Sequence 2

High fat diet+HIP1402 → fasted state+HIP1402 → High fat diet+HGP0412

Group Type EXPERIMENTAL

HIP1402

Intervention Type DRUG

Tamsulosin HCl 0.4mg

HGP0412

Intervention Type DRUG

Tamsulosin HCl 0.2mg

Sequence 3

fasted state+HIP1402 → High fat diet+HGP0412 → High fat diet+HIP1402

Group Type EXPERIMENTAL

HIP1402

Intervention Type DRUG

Tamsulosin HCl 0.4mg

HGP0412

Intervention Type DRUG

Tamsulosin HCl 0.2mg

Interventions

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HIP1402

Tamsulosin HCl 0.4mg

Intervention Type DRUG

HGP0412

Tamsulosin HCl 0.2mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy male volunteer, age 19\~50 years
2. Weight ≥55kg and ≤90kg, The result of Body Mass Index(BMI) is not less than 18 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. Systolic Blood Pressure: lower than 100mmHg or higher than 150mmHg, Diastolic Blood Pressure: lower than 60mmHg or higher than 100mmHg
4. Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
5. Subjects who took prescription drugs within 14 days from the patient screening or non-prescription medicine within 7 days which can affect the result of this clinical trial (acceptable according to the investigator's judgement)
6. Intake of more than 210g of alcohol per week or who can't abstain from alcohol during the trial.
7. Subjects who smoke more than 10 cigarettes per day or who can't quit smoking during the trial.
8. Positive screening on Hepatitis B surface antigen(HBsAg), anti-Hepatitis C virus(HCV) or anti-Human immunodeficiency virus(HIV).
9. Subjects who judged ineligible by the investigator.

Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes