To Evaluate Pharmacokinetics and Pharmacodynamics of Z-215 in Healthy Male Subjects

Zeria Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Z-215 10mg; Drug: Rabeprazole Sodium 20mg; Drug: Rabeprazole Sodium 10mg; Drug: Z-215 20mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02509923

Z215-02

Details and patient eligibility

About

The purpose of this study is to evaluate pharmacokinetics and pharmacodynamics of Z-215 (10 mg, 20 mg, 40 mg) , compared with Rabeprazole Sodium (10 mg, 20 mg ) in Healthy Male Subjects. And to evaluate food-effect in Healthy Male Subjects administrated Z-215 20 mg.

Enrollment: 54 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Has negative results for H. pylori IgG antibody at screening.
• A body mass index 18.5≦BMI<25.0 kg/m^2 at screening.
• Able to understand the consent of the study and comply with the study. Able to give informed consent in writing before participating in the study.

Exclusion criteria

• Has a history of PPI allergy.
• Has a history of drug or food serious allergy.
• Presently has or has a history of diseases that may affect evaluation of the study results such as gastrointestinal, hepatic, renal, respiratory, endocrine, blood, cardiovascular, mental or congenial metabolic disease.
• Has a history of surgery (such as resection of the liver, kidney, or digestive tract) that may affect the pharmacokinetics of the study drug.
• History of previous and current acid-related diseases.
• Received H. pylori eradication treatment within 6 months before screening.
• Has 450msec<QTC by Fridericia test at screening ECG .
• Has hypoacidity or anacidity. Or be determined that low gastric acid or no stomach acid by the gastric pH monitoring at baseline period.
• History or suspicion of drug, opioid, alcohol abuse or positive screening results.
• Use of any prescription drugs within 4 weeks prior to baseline period.
• Use of any over-the-counter drugs within 2 weeks prior to baseline period.
• Received blood transfusions within 12 weeks or donated ≥400mL of whole blood within 12 weeks or ≥200mL of whole blood within 4 weeks prior to baseline period. Donated platelet or plasma within 2 weeks prior to baseline period.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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54 participants in 3 patient groups

1

Experimental group

Description:

3-way cross-over, Z-215 10 mg/day / Z-215 20 mg/day / Rabeprazole Sodium 10 mg/day

Treatment:

Drug: Rabeprazole Sodium 10mg

Drug: Z-215 20mg

Drug: Z-215 10mg

2

Experimental group

Description:

3-way cross-over, Z-215 20 mg/day / Z-215 40 mg/day / Rabeprazole Sodium 20 mg/day

Treatment:

Drug: Rabeprazole Sodium 20mg

Drug: Z-215 20mg

3

Experimental group

Description:

3-way cross-over, Z-215 20 mg/day (before breakfast) / Z-215 20 mg/day (after breakfast) / Rabeprazole Sodium 10 mg/day (after breakfast)

Treatment:

Drug: Rabeprazole Sodium 10mg

Drug: Z-215 20mg