Safety and Pharmacokinetic Characteristics After Administration of HIP1503 and HGP1103 in Healthy Male Volunteers

NCT ID: NCT02940314

Last Updated: 2016-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-05-31

Brief Summary

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

Detailed Description

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Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sequence 1

HGP1103→HIP1503

Group Type EXPERIMENTAL

HIP1503

Intervention Type DRUG

HGP1103

Intervention Type DRUG

Sequence 2

HIP1503→HGP1103

Group Type EXPERIMENTAL

HIP1503

Intervention Type DRUG

HGP1103

Intervention Type DRUG

Interventions

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HIP1503

Intervention Type DRUG

HGP1103

Intervention Type DRUG

Other Intervention Names

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Solifenacin tartrate 10.66 mg Solifenacin succinate 10 mg

Eligibility Criteria

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Inclusion Criteria

1. Healthy male volunteers, age 19 to 45 years.
2. The result of Body Mass Index(BMI) 17.5 kg/m2\~ 30.5 kg/m2, body weight over 55kg.
3. 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.

Exclusion Criteria

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

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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HM-SOLT-101

Identifier Type: -

Identifier Source: org_study_id

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