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

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ClinicalTrials.gov Identifier: NCT00954291
Recruitment Status : Unknown
Verified September 2010 by Taipei Medical University WanFang Hospital.
Recruitment status was:  Recruiting
First Posted : August 7, 2009
Last Update Posted : September 6, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
The objective of the study is to characterize the pharmacokinetic profile of granisetron patch after single administration to healthy subjects.

Condition or disease
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 Design

Study Type : Observational
Estimated Enrollment : 8 participants
Observational Model: Case-Only
Official Title: An Open-label, Single Dose Pharmacokinetic Study of 14 mg Granisetron Patch in Healthy Subjects
Study Start Date : July 2009
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Granisetron
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Granisetron
14 mg Granisetron


Outcome Measures

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

Biospecimen Retention:   Samples Without DNA
plasma

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Health subjects
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00954291


Contacts
Contact: Hsingjin E Liu, MD, PhD 8862-29307930 ext 2548 liuxx086@yahoo.com.tw

Locations
Taiwan
Taipei Medical University - Municipal Wan Fang Hospital Recruiting
Taipei, Taiwan
Contact: Hsingjin E Liu, MD, PhD    8862-29307930 ext 2548    liuxx086@yahoo.com.tw   
Principal Investigator: Hsingjin E Liu, MD, PhD         
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Principal Investigator: Hsingjin E Liu, M.D. , Ph.D. Taipei Medical University - Municipal Wan Fang Hospital
More Information

Responsible Party: Hsingjin E. Liu, MD, PhD., Taipei Medical University - Municipal Wan Fang Hospital
ClinicalTrials.gov Identifier: NCT00954291     History of Changes
Other Study ID Numbers: L27GRA14-1
I805L27E01
First Posted: August 7, 2009    Key Record Dates
Last Update Posted: September 6, 2010
Last Verified: September 2010

Keywords provided by Taipei Medical University WanFang Hospital:
antinauseant and antiemetic

Additional relevant MeSH terms:
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Granisetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action