Investigating the Pharmacokinetic Characteristics of HIP1402 in Healthy Male Volunteers

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02529800

Enrollment

Registered

2015-08-20

Start date

2015-09-30

Completion date

2015-10-31

Last updated

2016-10-13

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

Conditions

Healthy

Brief summary

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

Detailed description

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

Interventions

DRUGHIP1402

Tamsulosin HCl 0.4mg

DRUGHGP0412

Tamsulosin HCl 0.2mg

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\ 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.

Design outcomes

Primary

Measure	Time frame
Tamsulosin, AUC(AUClast, AUCinf),	pre-dose(0 h), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-dose
Tamsulosin, Cmax	pre-dose(0 h), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-dose
Tamsulosin, Tmax	pre-dose(0 h), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-dose
Tamsulosin, t1/2	pre-dose(0 h), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-dose
Tamsulosin, CL/F	pre-dose(0 h), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-dose
Tamsulosin, Vz/F	pre-dose(0 h), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-dose

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026