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

NCT02715401 | Completed Phase 1

• 1 other identifier: HM-TASU-103
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Erectile Dysfunction; Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Sequence 1

EXPERIMENTAL

T → R T : HCP1303 R : HGP1201 + HIP1402

Drug: HCP1303; Drug: HGP1201; Drug: HIP1402

Sequence 2

EXPERIMENTAL

R → T T : HCP1303 R : HGP1201 + HIP1402

Drug: HCP1303; Drug: HGP1201; Drug: HIP1402

Interventions

HCP1303 DRUG

Sequence 1; Sequence 2

HGP1201 DRUG

Sequence 1; Sequence 2

HIP1402 DRUG

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male volunteer, age 19\~55 years
• The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
• Subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial
• Subject who has the ability and willingness to participate the whole period of trial

You may not qualify if:

• 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.
• History of relevant drug allergies or clinically significant hypersensitivity reaction.
• Glomerular filtration rate is under 60ml/min which is calculated by serum creatinine value.
• Liver enzyme (AST, ALT) level exceeds the maximum normal range more than one and a half times.
• SBP: lower than 90mmHg or higher than 150mmHg, DBP: lower than 60mmHg or higher than 100mmHg
• Subjects who judged ineligible by the investigator.

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

MeSH Terms

Conditions

Erectile Dysfunction; Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Prostatic Diseases

Study Officials

• Minsu Park, M.D., Ph.D.

  Yonsei University Health System, Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: March 22, 2016
• Study Start: October 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: March 22, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share