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

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

Study Overview

• Status: Unknown
• Conditions: Cancer; Vomiting

Detailed Description

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

• Study Type: Observational
• Enrollment (Anticipated): 8

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Taipei Medical University - Municipal Wan Fang Hospital
    • Contact: Hsingjin E Liu, MD, PhD; Phone Number: 2548 8862-29307930; Email: liuxx086@yahoo.com.tw
    • Principal Investigator: Hsingjin E Liu, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Health subjects

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Granisetron; 14 mg Granisetron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUC0-t, AUC0-µ, Cmax, Tmax, T1/2, and MRT in plasma were determined with granisetron concentrations by non-compartment methods.	7 days

Collaborators and Investigators

• Sponsor: Taipei Medical University WanFang Hospital
• Investigators: Principal Investigator: Hsingjin E Liu, M.D., Ph.D., Taipei Medical University - Municipal Wan Fang Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Anticipated): August 1, 2009
• Study Completion (Anticipated): August 1, 2009

Study Registration Dates

• First Submitted: August 6, 2009
• First Submitted That Met QC Criteria: August 6, 2009
• First Posted (Estimate): August 7, 2009

Study Record Updates

• Last Update Posted (Estimate): September 6, 2010
• Last Update Submitted That Met QC Criteria: September 3, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: antinauseant and antiemetic
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Vomiting
• Other Study ID Numbers: L27GRA14-1; I805L27E01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No