慢性心絞痛

此試驗目的在於評估兩種不同處方之ranolazine 500毫克緩釋錠劑（ranolazine 500毫克緩釋錠劑；兩種不同處方試驗藥品Test-1及Test-2）與Ranexa®（ranolazine 500毫克緩釋錠劑），於台灣健康受試者中分別於空腹狀態和進食狀態下評估兩藥品生體相等性。

Ranolazine 500毫克緩釋錠劑

Ranolazine

Extended-release tablet

500

1. Primary endpoint(s):
Bioequivalence will be assumed if the 90% confidence interval of the AUC0-t, AUC0-¥ and Cmax ratio are within the 80-125% interval for log-transformed values.

2. Secondary endpoints:
The other PK-variables will be assessed for description purposes. As safety parameters adverse events and vital signs (blood pressure, heart rate and body temperature) will be recorded.

1. Inclusion criteria:

1. Provision of signed written informed consent before enrollment into the study, ability to communicate
with the investigators, and to understand and comply with the requirements of the study.
2. Healthy adult male, aged between 20 and 40 years old.
3. Body Mass Index (BMI) between 18.5 and 25, inclusive, (BMI will be calculated as weight in kilogram [kg]/height in meters2 [m2]).
4. Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest x-ray and electrocardiogram.
5. No significant deviation from normal biochemistry examination.
6. No significant deviation from normal hematology examination.
7. No significant deviation from normal urinalysis examination.

2. Exclusion criteria:

1. History of drug or alcohol abuse within the past year.
2. Medical history of severe drug allergy or sensitivity to analogous drug.
3. Evidence of acute or chronic diseases or having undergone surgery from 4 weeks prior to Period I dosing.
4. Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoietic, neurological, pulmonary or gastrointestinal pathology.
5. Ongoing peptic ulcer and constipation.
6. Planned vaccination during the time course of the study.
7. Taking any clinical investigation drug from 2 months prior to Period I dosing.
8. Use of any medication, including herb medicine from 4 weeks before the study.
9. Blood donation of more than 500 mL within the past 3 months.
10. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result.
11. A positive test for HIV antibody.