[KJ-INT-002] BE Study

Kukje Pharma

Status and phase: Unknown; Phase 1

Conditions: Gastritis

Treatments: Drug: INT-2150; Drug: Irsogladine maleate 2 mg+Nizatidine 150 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03509831

KJ-INT-002

Details and patient eligibility

About

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

Enrollment: 37 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

INT2150-A

Other group

Treatment:

Drug: Irsogladine maleate 2 mg+Nizatidine 150 mg

Drug: INT-2150

INT2150-B

Other group

Treatment:

Drug: Irsogladine maleate 2 mg+Nizatidine 150 mg

Drug: INT-2150