[KJ-INT-002] BE Study

Phase 1

• Conditions: Gastritis
• Interventions: Drug: INT-2150; Drug: Irsogladine maleate 2 mg+Nizatidine 150 mg

• Registration Number: NCT03509831
• Lead Sponsor: Kukje Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-02
• Primary Completion: 2018-01-24
• Status Verified: 2018-04
• Study Completion: 2018-04
• Study First Submitted: 2018-04-05
• Study First Submitted QC: 2018-04-17
• Last Update Submitted: 2018-04-17
• Study First Posted: 2018-04-26
• Last Update Posted: 2018-04-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 37

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
INT2150-B	Irsogladine maleate 2 mg+Nizatidine 150 mg	-
INT2150-A	INT-2150	-
INT2150-A	Irsogladine maleate 2 mg+Nizatidine 150 mg	-
INT2150-B	INT-2150	-

Primary Outcome Measures

Name	Time	Method
Cmax	One day	Pharmacokinetic Characteristics
AUCt	One day	Pharmacokinetic Characteristics

Secondary Outcome Measures

Name	Time	Method
AUC∞	One day	Pharmacokinetic Characteristics
tmax	One day	Pharmacokinetic Characteristics
t1/2	One day	Pharmacokinetic Characteristics

Trial Locations

Locations (1)

Kukje Pharm; 🇰🇷 Seongnam-si, Korea, Republic of