Investigating the Pharmacokinetic Characteristics of HIP1402 in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: HIP1402; Drug: HGP0412

• Registration Number: NCT02529800
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

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

Study Timeline

• Study First Submitted: 2015-08-13
• Study First Submitted QC: 2015-08-19
• Study First Posted: 2015-08-20
• Study Start: 2015-09
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-12
• Last Update Posted: 2016-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	HGP0412	High fat diet+HGP0412 → High fat diet+HIP1402 → fasted state+HIP1402
Sequence 1	HIP1402	High fat diet+HGP0412 → High fat diet+HIP1402 → fasted state+HIP1402
Sequence 2	HIP1402	High fat diet+HIP1402 → fasted state+HIP1402 → High fat diet+HGP0412
Sequence 2	HGP0412	High fat diet+HIP1402 → fasted state+HIP1402 → High fat diet+HGP0412
Sequence 3	HIP1402	fasted state+HIP1402 → High fat diet+HGP0412 → High fat diet+HIP1402
Sequence 3	HGP0412	fasted state+HIP1402 → High fat diet+HGP0412 → High fat diet+HIP1402

Primary Outcome Measures

Name	Time	Method
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