Clinical trial NCT02529800: Investigating the Pharmacokinetic Characteristics of HIP1402 in Healthy Male Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2015-08-20
Enrollment: 24
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Tamsulosin, AUC(AUClast, AUCinf),
timeFrame: pre-dose(0 h), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-dose
measure: Tamsulosin, Cmax
timeFrame: pre-dose(0 h), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-dose
measure: Tamsulosin, Tmax
timeFrame: pre-dose(0 h), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-dose
measure: Tamsulosin, t1/2
timeFrame: pre-dose(0 h), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-dose
measure: Tamsulosin, CL/F
timeFrame: pre-dose(0 h), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-dose
measure: Tamsulosin, Vz/F
timeFrame: pre-dose(0 h), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 h post-dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Kyung-Sang Yu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.