Status:
COMPLETED
PK, Tolerability and Safety of the Co-administration of Sancuso® (Transdermal Granisetron) and IV Granisetron
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Healthy
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This study has been designed to investigate the pharmacokinetic and safety profile of the co-administration of intravenous (IV) and transdermal granisetron, as well as characterise the pharmacokinetic...
Detailed Description
Sancuso® is designed to provide antiemetic prophylaxis for chemotherapy of up to 5 days duration. In exceptional clinical situations in which the patch is not applied at the appropriate time (i.e. 24-...
Eligibility Criteria
Inclusion
- Healthy male or female Caucasian subjects
- Aged between 18 and 70 years, inclusive, at screening
- BMI between 20.0 and 29.9 kg/m², inclusive.
- Must demonstrate understanding of the purposes and risks of the study
- Must agree to follow the restrictions and schedule of study procedures
Exclusion
- Current or previous disease, disorder, allergy or condition that could affect study conduct or laboratory assessments, or that presents undue risk from study medication or procedures.
- Physical examination or screening investigation result that indicates subject is unfit for the study.
- Scarring on upper arms.
- Positive virology, urine drugs of abuse or pregnancy test result (females of childbearing potential only).
- Recent use of prescribed or over the counter medication.
- Participation in any clinical study or loss of ≥ 400 mL of blood (e.g. been a blood donor) within the previous 60 days.
- Average weekly alcohol consumption of greater than 21 units (males) or 14 units (females), or habitually smokes ≥ 5 cigarettes or equivalent tobacco per day within the 6 months before the first study drug administration.
- Lactating female subjects and female subjects of childbearing potential who are not willing to use an acceptable form of contraception during and for 90 days after the study.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00873197
Start Date
April 1 2009
End Date
May 1 2009
Last Update
June 17 2024
Active Locations (1)
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1
Charles River Clinical Services Edinburgh Ltd
Edinburgh, United Kingdom, EH33 2NE