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An Open-label, Single Dose Pharmacokinetic Study of 14 mg Granisetron Patch in Healthy Subjects

20 Years
40 Years
Open (Enrolling)
Cancer, Vomiting

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Trial Information

An Open-label, Single Dose Pharmacokinetic Study of 14 mg Granisetron Patch in Healthy Subjects

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

Inclusion Criteria:

1. Subjects must be male at the age of 20-40 years old 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 above 50 kg and within -20 to +20% of ideal body weight.

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:

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. Individuals are judged by the investigator or pharmacokineticist to be undesirable as
subjects for other reasons.

Type of Study:


Study Design:

Observational Model: Case-Only

Outcome Measure:

AUC0-t, AUC0-µ, Cmax, Tmax, T1/2, and MRT in plasma were determined with granisetron concentrations by non-compartment methods.

Outcome Time Frame:

7 days

Safety Issue:


Principal Investigator

Hsingjin E Liu, M.D. , Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Taipei Medical University - Municipal Wan Fang Hospital


Taiwan: Department of Health

Study ID:




Start Date:

July 2009

Completion Date:

August 2009

Related Keywords:

  • Cancer
  • Vomiting
  • antinauseant and antiemetic
  • Vomiting