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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Taipei Medical University WanFang Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT00954291
First received: August 6, 2009
Last updated: September 3, 2010
Last verified: September 2010
  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: Observational Model: 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 Medical University WanFang 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Study First Received: August 6, 2009
Last Updated: September 3, 2010
Health Authority: Taiwan: Department of Health

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 19, 2014