NCT02940314

Brief Summary

The purpose of this study is to compare the safety and pharmacokinetic characteristics after administration of HIP1503 and HGP1103 in healthy male volunteers.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_1

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

March 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 20, 2016

Completed
Last Updated

October 20, 2016

Status Verified

October 1, 2016

Enrollment Period

2 months

First QC Date

October 19, 2016

Last Update Submit

October 19, 2016

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (2)

  • AUClast

    0h(Predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72hours (total 14)

  • Solifenacin Cmax

    0h(Predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72hours (total 14)

Secondary Outcomes (3)

  • Solifenacin AUCinf

    0h(Predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72hours (total 14)

  • Solifenacin Tmax

    0h(Predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72hours (total 14)

  • Solifenacin t1/2

    0h(Predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72hours (total 14)

Study Arms (2)

sequence 1

EXPERIMENTAL

HGP1103→HIP1503

Drug: HIP1503Drug: HGP1103

Sequence 2

EXPERIMENTAL

HIP1503→HGP1103

Drug: HIP1503Drug: HGP1103

Interventions

HIP1503DRUG
Also known as: Solifenacin tartrate 10.66 mg
Sequence 2sequence 1
HGP1103DRUG
Also known as: Solifenacin succinate 10 mg
Sequence 2sequence 1

Eligibility Criteria

Age19 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male volunteers, age 19 to 45 years.
  • The result of Body Mass Index(BMI) 17.5 kg/m2\~ 30.5 kg/m2, body weight over 55kg.
  • 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.

You may not qualify if:

  • Presence of medical history or a concurrent disease, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
  • Medical history of Gastrointestinal Diseases that effects drug absorption (esophageal disease, chronic disease) or surgery( except appendectomy , herniolaparotomy)
  • sit SBP \> 140 mmHg, sit DBP \> 90 mmHg
  • Alcohol or Drug abuse within 1 year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

QuinuclidinesHeterocyclic Compounds, Bridged-RingHeterocyclic CompoundsTetrahydroisoquinolinesIsoquinolinesHeterocyclic 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

October 19, 2016

First Posted

October 20, 2016

Study Start

March 1, 2016

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

October 20, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share