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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Overactive Bladder

Treatments: Drug: HGP1103; Drug: HIP1503

Study type: Interventional

Funder types: Industry

Identifiers

NCT02940314

HM-SOLT-101

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

sequence 1

Experimental group

Description:

HGP1103→HIP1503

Treatment:

Drug: HIP1503

Drug: HGP1103

Sequence 2

Experimental group

Description:

HIP1503→HGP1103

Treatment:

Drug: HIP1503

Drug: HGP1103