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

A Randomized, Open-label, Single Dose, 2-way Crossover Study to Compare the Safety and Pharmacokinetic Characteristics After Administration of HIP1503 and HGP1103 in Healthy Male Volunteers

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

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: HIP1503; Drug: HGP1103

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sequence 1; HGP1103→HIP1503	Drug: HIP1503; Other Names: Solifenacin tartrate 10.66 mg; Drug: HGP1103; Other Names: Solifenacin succinate 10 mg
Experimental: Sequence 2; HIP1503→HGP1103	Drug: HIP1503; Other Names: Solifenacin tartrate 10.66 mg; Drug: HGP1103; Other Names: Solifenacin succinate 10 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: October 19, 2016
• First Submitted That Met QC Criteria: October 19, 2016
• First Posted (Estimate): October 20, 2016

Study Record Updates

• Last Update Posted (Estimate): October 20, 2016
• Last Update Submitted That Met QC Criteria: October 19, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Solifenacin Succinate
• Other Study ID Numbers: HM-SOLT-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO