PK and Safety of HCP1303 and Co-administration of HGP1201, HIP1402 Under Fed Condition in Healthy Male Volunteers

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Erectile Dysfunction; Prostatic Hyperplasia

Treatments: Drug: HIP1402; Drug: HCP1303; Drug: HGP1201

Study type: Interventional

Funder types: Industry

Identifiers

NCT02715401

HM-TASU-103

Details and patient eligibility

About

To investigate the pharmacokinetic properties and safety after administration of HCP1303 and co-administration of HGP1201, HIP1402 under Fed Condition in healthy male volunteers

Full description

The purpose of this study is to investigate the Pharmacokinetic Properties and Safety after administration of HCP1303 capsule and Co-administration of HGP1201 tablet, HIP1402 capsule under Fed Condition in Healthy Male Volunteers

Enrollment: 36 patients

Sex: Male

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male volunteer, age 19~55 years
2. The result of Body Mass Index(BMI) is not less than 19 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. Glomerular filtration rate is under 60ml/min which is calculated by serum creatinine value.
4. Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
5. SBP: lower than 90mmHg or higher than 150mmHg, DBP: lower than 60mmHg or higher than 100mmHg
6. Subjects who judged ineligible by the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Sequence 1

Experimental group

Description:

T → R T : HCP1303 R : HGP1201 + HIP1402

Treatment:

Drug: HGP1201

Drug: HIP1402

Drug: HCP1303

Sequence 2

Experimental group

Description:

R → T T : HCP1303 R : HGP1201 + HIP1402

Treatment:

Drug: HGP1201

Drug: HIP1402

Drug: HCP1303