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An Open-label, Single Dose Pharmacokinetic Study of 14 mg Granisetron Patch in Healthy Subjects
This study is currently recruiting participants.
Verified by Taipei Municipal Wan Fang Hospital, August 2009
First Received: August 6, 2009   No Changes Posted
Sponsors and Collaborators: Taipei Municipal Wan Fang Hospital
Rosetta Pharmamate Co., Ltd
Genovate Biotechnology Co., Ltd.,
Information provided by: Taipei Municipal Wan Fang Hospital
ClinicalTrials.gov Identifier: NCT00954291
  Purpose

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


Condition
Cancer
Vomiting

Study Type: Observational
Study Design: Case-Only
Official Title: An Open-label, Single Dose Pharmacokinetic Study of 14 mg Granisetron Patch in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Taipei Municipal Wan Fang Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

plasma


Estimated Enrollment: 8
Study Start Date: July 2009
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Granisetron
14 mg Granisetron

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Municipal Wan Fang Hospital
Rosetta Pharmamate Co., Ltd
Genovate Biotechnology Co., Ltd.,
Investigators
Principal Investigator: Hsingjin E Liu, M.D. , Ph.D. Taipei Medical University - Municipal Wan Fang Hospital
  More Information

No publications provided

Responsible Party: Taipei Medical University - Municipal Wan Fang Hospital ( Hsingjin E. Liu, MD, PhD. )
Study ID Numbers: L27GRA14-1, I805L27E01
Study First Received: August 6, 2009
Last Updated: August 6, 2009
ClinicalTrials.gov Identifier: NCT00954291     History of Changes
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Municipal Wan Fang Hospital:
antinauseant and antiemetic

Study placed in the following topic categories:
Neurotransmitter Agents
Vomiting
Antiemetics
Peripheral Nervous System Agents
Granisetron
Healthy
Serotonin

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Antiemetics
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Autonomic Agents
Therapeutic Uses
Granisetron
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 11, 2009