NCT02529800

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 20, 2015

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 13, 2016

Status Verified

October 1, 2016

Enrollment Period

1 month

First QC Date

August 13, 2015

Last Update Submit

October 12, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (3)

Sequence 1

EXPERIMENTAL

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

Drug: HIP1402Drug: HGP0412

Sequence 2

EXPERIMENTAL

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

Drug: HIP1402Drug: HGP0412

Sequence 3

EXPERIMENTAL

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

Drug: HIP1402Drug: HGP0412

Interventions

HIP1402DRUG

Tamsulosin HCl 0.4mg

Sequence 1Sequence 2Sequence 3
HGP0412DRUG

Tamsulosin HCl 0.2mg

Sequence 1Sequence 2Sequence 3

Eligibility Criteria

Age19 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male volunteer, age 19\~50 years
  • Weight ≥55kg and ≤90kg, The result of Body Mass Index(BMI) is not less than 18 kg/m2 , no more than 27 kg/m2
  • Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
  • Subject who has the ability and willingness to participate the whole period of trial

You may not qualify if:

  • 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.
  • History of relevant drug allergies or clinically significant hypersensitivity reaction.
  • Systolic Blood Pressure: lower than 100mmHg or higher than 150mmHg, Diastolic Blood Pressure: lower than 60mmHg or higher than 100mmHg
  • Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
  • 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)
  • Intake of more than 210g of alcohol per week or who can't abstain from alcohol during the trial.
  • Subjects who smoke more than 10 cigarettes per day or who can't quit smoking during the trial.
  • Positive screening on Hepatitis B surface antigen(HBsAg), anti-Hepatitis C virus(HCV) or anti-Human immunodeficiency virus(HIV).
  • Subjects who judged ineligible by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ban MS, Kim YK, Kim B, Jung J, Kim YI, Oh J, Yu KS. Evaluation of the pharmacokinetics and food effects of a novel formulation tamsulosin 0.4 mg capsule compared with a 0.2 mg capsule in healthy male volunteers. Transl Clin Pharmacol. 2020 Dec;28(4):181-188. doi: 10.12793/tcp.2020.28.e17. Epub 2020 Nov 24.

    PMID: 33425801DERIVED

Study Officials

  • Kyung-Sang Yu, M.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2015

First Posted

August 20, 2015

Study Start

September 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

October 13, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share