A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HIP1801 in Healthy Male Subjects.

Sponsor

Hanmi Pharmaceutical Company Limited (Industry)

Overall Status

Completed

CT.gov ID

NCT04084197

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Days)

116

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics, safety and tolerability of HIP1801 in healthy male subjects.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: HIP1402 Drug: HIP1801	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-label, Randomized, Single-dose Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HIP1801 in Healthy Male Subjects

Actual Study Start Date :

Dec 19, 2018

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Jan 4, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sequence 1 Period 1 : Fasted state + HIP1402, Period 2 : Fasted state + HIP1801	Drug: HIP1402 Tamsulosin (HanmiTams Capsule) 0.4mg Drug: HIP1801 Tamsulosin 0.4mg
Experimental: Sequence 2 Period 1 : Fasted state + HIP1801, Period 2 : Fasted state + HIP1402	Drug: HIP1402 Tamsulosin (HanmiTams Capsule) 0.4mg Drug: HIP1801 Tamsulosin 0.4mg
Experimental: Sequence 3 High fat diet + HIP1402, Period 2 : High fat diet + HIP1801	Drug: HIP1402 Tamsulosin (HanmiTams Capsule) 0.4mg Drug: HIP1801 Tamsulosin 0.4mg
Experimental: Sequence 4 High fat diet + HIP1801, Period 2 : High fat diet + HIP1402	Drug: HIP1402 Tamsulosin (HanmiTams Capsule) 0.4mg Drug: HIP1801 Tamsulosin 0.4mg

Outcome Measures

Primary Outcome Measures

Cmax of Tamsulosin [pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour]
pharmacokinetic evaluation
AUClast of Tamsulosin [pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour]
pharmacokinetic evaluation

Secondary Outcome Measures

AUCinf of Tamsulosin [pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour]
pharmacokinetic evaluation
Tmax of Tamsulosin [pre-dose(0 hour), 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48 hour]
pharmacokinetic evaluation
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]
pharmacokinetic evaluation
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]
pharmacokinetic evaluation
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]
pharmacokinetic evaluation

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Korea University Anam Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

Hanmi Pharmaceutical Company Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hanmi Pharmaceutical Company Limited

ClinicalTrials.gov Identifier:

NCT04084197

Other Study ID Numbers:

HM-TOD-101

First Posted:

Sep 10, 2019

Last Update Posted:

Sep 10, 2019

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 10, 2019