NCT01514903

Brief Summary

This is a single dose open-label comparative pharmacokinetic study to assess the pharmacokinetic characteristics of sildenafil between HIP0908 (chewable tablet) and Viagra (tablet) in healthy male subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 23, 2012

Completed
Last Updated

October 12, 2016

Status Verified

October 1, 2016

Enrollment Period

Same day

First QC Date

January 18, 2012

Last Update Submit

October 11, 2016

Conditions

Erectile Dysfunction

Keywords

anti erectile dysfunction agent

Outcome Measures

Primary Outcomes (1)

  • AUC and Cmax of sildenafil

    Pre-dose (0h), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14 hr post-dose

Study Arms (2)

viagra,anti-erectile dysfunction agent

ACTIVE COMPARATOR
Drug: viagra

HIP0908

EXPERIMENTAL
Drug: HIP0908

Interventions

HIP0908DRUG

SINGLE DOSE , CROSS OVER

HIP0908
viagraDRUG

single dose, cross over

viagra,anti-erectile dysfunction agent

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age between 20 and 45
  • weight : over 55kg and 18.5 \< BMI, 25.0
  • have to give their consent to participating clinical trial by oneself

You may not qualify if:

  • has a medical history of hypersensitivity to drug including PDE5 inhibitor and QTc \> 430ms or uncontrolled arrhythmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sinchon Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

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 18, 2012

First Posted

January 23, 2012

Study Start

December 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

October 12, 2016

Record last verified: 2016-10

Locations

KR(1)