[KJ-INT-002] BE Study

NCT ID: NCT03509831

Last Updated: 2018-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-02
• Study Completion Date: 2018-04-30

Brief Summary

Assess the Safety and the Pharmacokinetic Characteristics of INT-2150 after Oral Administration to Healthy Adult Male Subjects

Conditions

Gastritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

INT2150-A

Group Type: OTHER

INT-2150

Intervention Type: DRUG

1. Period: INT-2150

2. Period: Irsogladine maleate 2 mg+Nizatidine 150 mg

Irsogladine maleate 2 mg+Nizatidine 150 mg

Intervention Type: DRUG

1. Period: Irsogladine maleate 2 mg+Nizatidine 150 mg

2. Period: INT-2150

INT2150-B

Group Type: OTHER

INT-2150

Intervention Type: DRUG

1. Period: INT-2150

2. Period: Irsogladine maleate 2 mg+Nizatidine 150 mg

Irsogladine maleate 2 mg+Nizatidine 150 mg

Intervention Type: DRUG

1. Period: Irsogladine maleate 2 mg+Nizatidine 150 mg

2. Period: INT-2150

Interventions

INT-2150

1. Period: INT-2150

2. Period: Irsogladine maleate 2 mg+Nizatidine 150 mg

Intervention Type: DRUG

Irsogladine maleate 2 mg+Nizatidine 150 mg

1. Period: Irsogladine maleate 2 mg+Nizatidine 150 mg

2. Period: INT-2150

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male aged between 19 and 45 years of age inclusive, at the time of signing the informed consent.

2. Body weight >= 50 kilogram (kg) and body mass index within the range 18 - 29.0kg/m^2 (inclusive).

3. Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.

4. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form

Exclusion Criteria

1. Patients with a history of abnormal digestive organ, kidney, respiratory, neuroendocrine, cardiovascular, hemato-oncology, urinary, muscloskeletal, immune, the nose and ears, psychiatry, stomach system.

2. History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator contraindicates their participation.

3. Systolic blood pressure ≥ 150 or ≤ 100 mmHg, Diasolic blood pressure ≥ 95 or ≤ 55 mmHg.

4. Gastrointestinal disease or with gastrointestinal surgical history which can affect the absorption of the investigational product.

5. Alanine aminotransferase, alkaline phosphatase <=2x upper limit of normal (ULN) total bilirubin > 2.0mg/dl and eGRF <60mL/min/1.73m2

6. History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >21 units for males. One unit is equivalent to 10 gram of alcohol.

7. The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 90 days of the biological effect of the investigational product (whichever is longer).

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kukje Pharma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sang-Heon Cho

Role: PRINCIPAL_INVESTIGATOR

Inha University Hospital

Locations

Kukje Pharm

Seongnam-si, , South Korea

Countries

South Korea

Other Identifiers

KJ-INT-002

Identifier Type: -

Identifier Source: org_study_id