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

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02940314
• Other study ID #: HM-SOLT-101
• Status: Completed
• Phase: Phase 1
• First received: October 19, 2016
• Last updated: October 19, 2016
• Start date: March 2016
• Est. completion date: May 2016

Study information

• Verified date: October 2016
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 19 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• HIP1503

• HGP1103

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUClast		0h(Predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72hours (total 14)	No
Primary	Solifenacin Cmax		0h(Predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72hours (total 14)	No
Secondary	Solifenacin AUCinf		0h(Predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72hours (total 14)	No
Secondary	Solifenacin Tmax		0h(Predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72hours (total 14)	No
Secondary	Solifenacin t1/2		0h(Predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72hours (total 14)	No