A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HIP1801 in Healthy Male Subjects.
An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HIP1801 in Healthy Male Subjects
1 other identifier
interventional
61
1 country
1
Brief Summary
An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HIP1801 in healthy male subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Dec 2018
Shorter than P25 for phase_1 healthy
1 active site
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
Study Start
First participant enrolled
December 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 4, 2019
CompletedFirst Submitted
Initial submission to the registry
September 9, 2019
CompletedFirst Posted
Study publicly available on registry
September 10, 2019
CompletedSeptember 10, 2019
September 1, 2019
12 days
September 9, 2019
September 9, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Cmax of Tamsulosin
pharmacokinetic evaluation
pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour
AUClast of Tamsulosin
pharmacokinetic evaluation
pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour
Secondary Outcomes (5)
AUCinf of Tamsulosin
pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour
Tmax of Tamsulosin
pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour
t1/2 of Tamsulosin
pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour
CL/F of Tamsulosin
pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour
Vd/F of Tamsulosin
pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour
Study Arms (4)
Sequence 1
EXPERIMENTALPeriod 1 : Fasted state + HIP1402, Period 2 : Fasted state + HIP1801
Sequence 2
EXPERIMENTALPeriod 1 : Fasted state + HIP1801, Period 2 : Fasted state + HIP1402
Sequence 3
EXPERIMENTALHigh fat diet + HIP1402, Period 2 : High fat diet + HIP1801
Sequence 4
EXPERIMENTALHigh fat diet + HIP1801, Period 2 : High fat diet + HIP1402
Interventions
Eligibility Criteria
You may qualify if:
- Age 19\~45 years in healthy male volunteers
- BMI is more than 18.5 kg/m\^2 , no more than 29.9 kg/m\^2
- Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing
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 digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
- Subjects who judged ineligible by the investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Korea University Anam Hospital
Seoul, South Korea
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
September 9, 2019
First Posted
September 10, 2019
Study Start
December 19, 2018
Primary Completion
December 31, 2018
Study Completion
January 4, 2019
Last Updated
September 10, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share