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

Erectile Dysfunction Clinical Trial

Official title:

A Randomized, Open-Label, Crossover, Single-Dose Study to Compare Pharmacokinetic Properties and Safety After Administration of HCP1303 Capsule and Co-administration of HGP1201 Tablet, HIP1402 Capsule Under Fed Condition in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02715401
• Other study ID #: HM-TASU-103
• Status: Completed
• Phase: Phase 1
• First received: January 29, 2016
• Last updated: March 21, 2016
• Start date: October 2015
• Est. completion date: November 2015

Study information

• Verified date: March 2016
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Drug:
• HCP1303

• HGP1201

• HIP1402

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUClast		Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose	Yes
Primary	Cmax		Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose	Yes
Secondary	AUCinf		Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose	Yes
Secondary	tmax		Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose	Yes
Secondary	t1/2		Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose	Yes
Secondary	Cl/F		Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose	Yes
Secondary	Vd/F		Pre-dose(0h), 0.5, 1, 1.5, 2, 2.5, 3, 4, 4.5, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72 hours post-dose	Yes