預防及治療抗腫瘤化學療法所引起的噁心、嘔吐及治療抗腫瘤放射線療法引起的噁心、嘔吐。預防全身性及半身性抗腫瘤放射線療法引起的噁心、嘔吐。治療手術後引起的噁心、嘔吐

The objective of the study is to characterize the pharmacokinetic profile of granisetron patch after repeated administrations to healthy subjects.

granisetron Transdermal patch 14毫克

granisetron

Transdermal patch

14毫克

希望藉由測定granisetron在人體內之吸收速率與吸收程度，來評估健亞生物科技股份有限公司所開發之granisetron貼片的藥物動力學特性(指人體對藥品的吸收、分佈、代謝與排除等特性)。

Inclusion criteria:
Subjects will be enrolled into the study according to the following criteria:
1. Subjects must be adults in good health on the basis of medical history, physical examination, electrocardiogram, chest X-ray, and routine laboratory evaluations.
2. Vital signs (after 3 minutes resting in a upright position) which are within the following ranges: Ear body temperature between 35.0-37.5 °C.Systolic blood pressure, 90-140 mm Hg.Diastolic blood pressure, 50-90 mm Hg.Pulse rate, 50-90 bpm.Fasting blood glucose, < 100 mg/dL.
3. Body weight must be within -20 to +20% of ideal body weight. Male subjects must be over 50 kg and female subjects must be over 45 kg.
4. Able to sign informed consent prior to study.
5. Able to communicate well with the investigator and comply with the requirements of the study.

Exclusion criteria:
Subjects meet any of the following criteria during pre-study examination evaluation will be excluded from entry into or continuation in the study:
1. Use of any prescription medication within 14 days prior to dosing.
2. Use of over-the-counter medications or vitamins within 14 days prior to dosing.
3. Significant illness within 2 weeks prior to dosing.
4. Participation in any clinical investigation within 2 months prior to dosing or longer than required by local regulation.
5. Donate or loss more than 500 mL of blood within 3 months prior to dosing.
6. Presence of cardiovascular disease.
7. Presence of gastrointestinal disease.
8. Presence of asthma or lung disease.
9. Presence of liver disease, hepatitis B, hepatitis C or liver injury as indicated by an abnormal liver function profile such as GOT, GPT, g-GT, alkaline phosphatase, serum bilirubin, HBsAg, or Anti-HCV.
10. Presence of impaired renal function as indicated by abnormal creatinine or BUN values or abnormal urinary constituents (e.g., albuminuria).
11. Presence of neurological disease.
12. Presence of psychiatrical disease.
13. Subject is known for HIV infected.
14. A known hypersensitivity to granisetron or its analogs.
15. History of drug or alcohol abuse within 12 months prior to dosing.
16. Permanent confinement to an institution.
17. Pregnant or lactating women.
18. Individuals are judged by the investigator or pharmacokineticist to be undesirable as subjects for other reasons.