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
Recruitment status was Recruiting
Sponsor:
Taipei Medical University WanFang Hospital
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
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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:
- 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.
- 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.
- Body weight must be above 50 kg and within -20 to +20% of ideal body weight.
- Able to sign informed consent prior to study.
- Able to communicate well with the investigator and comply with the requirements of the study.
Exclusion Criteria:
- Use of any prescription medication within 14 days prior to dosing.
- Use of over-the-counter medications or vitamins within 14 days prior to dosing.
- Significant illness within 2 weeks prior to dosing.
- Participation in any clinical investigation within 2 months prior to dosing or longer than required by local regulation.
- Donate or loss more than 500 mL of blood within 3 months prior to dosing.
- Presence of cardiovascular disease.
- Presence of gastrointestinal disease.
- Presence of asthma or lung disease.
- 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.
- Presence of impaired renal function as indicated by abnormal creatinine or BUN values or abnormal urinary constituents (e.g., albuminuria).
- Presence of neurological disease.
- Presence of psychiatrical disease.
- Subject is known for HIV infected.
- A known hypersensitivity to granisetron or its analogs.
- History of drug or alcohol abuse within 12 months prior to dosing.
- Permanent confinement to an institution.
- 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 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 June 17, 2013