PK, Tolerability and Safety of the co-Administration of Sancuso® (Transdermal Granisetron) and IV Granisetron

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

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 pharmacokinetics of multiple transdermal dosing.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Prostrakan Pharmaceuticals
• Treatments: Granisetron

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.