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Effect of External Heat on a Transdermal Granisetron Patch in Pharmacokinetics (PK) of Healthy Subjects

Information source: Prostrakan Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: granisetron IV (Drug); granisetron patch (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Prostrakan Pharmaceuticals

Official(s) and/or principal investigator(s):
Stuart J Mair, Principal Investigator, Affiliation: Quotient Clinical Limited

Summary

The purpose of this study is to determine the effect of heat applied to a granisetron transdermal patch in healthy subjects.

Clinical Details

Official title: A Phase I Study to Evaluate the Effect of External Heat on the Pharmacokinetics of a Transdermal Granisetron Patch in Healthy Subjects

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Pharmacokinetic profile of the granisetron patch in healthy subjects when heat is applied

Secondary outcome:

Safety and tolerability assessment

residual granisetron after patch use in healthy subjects

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy male or female subjects aged ≥ 18 and ≤ 45 years at screening. Subjects must

demonstrate understanding of the purposes and risks of the study and agree to follow the restrictions and schedule of study procedures, as evidenced by voluntary written informed consent (signed and dated) obtained before taking part in any trial-related activities. Exclusion Criteria:

- Any current or previous disease, disorder, allergy or condition (including recent

unexplained weight loss) that could affect the study conduct or laboratory assessments, or that presents undue risk from the study medication or procedures. Hypersensitivity to adhesive plasters or surgical tape.

- Any physical examination or screening investigation result that indicates the subject

is unfit for the study.

- Scarring on upper arms, including extensive tattoos making skin reactions

unevaluable.

- A positive virology test, urine test for drugs of abuse, or pregnancy test result

(females of childbearing potential only).

- Recent use of prescribed or over-the-counter medication that, in the opinion of the

Investigator or the Sponsor, will interfere with the study procedures or compromise safety.

- Received an investigational drug within 3 months (90 days) preceding patch

application.

- Loss of ≥ 400 mL of blood (e. g. been a blood donor) within the past 3 months.

- 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 patch application. Subjects may not smoke while confined to the study site. Subjects must not consume alcohol, or xanthine-containing foods or drinks within 48 hours prior to dosing until discharge.

- Lactating female subjects, and female subjects of childbearing potential who are not

willing to use an acceptable form of contraception from the screening visit, during the study and for 90 days after the study.

- Employee of the Investigator or study centre, with direct involvement in the proposed

study or other studies under the direction of that Investigator or study centre, as well as family members of the employees or the Investigator.

Locations and Contacts

Quotient Clinical Limited, Origo Centre, Riccarton, Edinburgh EH14 4AP, United Kingdom
Additional Information

Starting date: March 2010
Last updated: September 24, 2010

Page last updated: August 23, 2015

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