DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Study in Healthy Volunteers to Prove That Two Different Formulations of Rotigotine Patches Deliver Equivalent Drug Amount to the Body

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

Condition(s) targeted: Healthy Volunteers

Intervention: Rotigotine transdermal patch (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: UCB Pharma

Official(s) and/or principal investigator(s):
UCB Clinical Trial Call Center, Study Director, Affiliation: +1 877 822 9493 (UCB)

Summary

The major aim of this study is to investigate and compare the drug amount delivered to the body after sequential application of two Rotigotine patches of two different formulations

Clinical Details

Official title: Single-site, Open-label, Randomized, Cross-over Trial to Evaluate the Bioequivalence of Single Dose Rotigotine Transdermal Patch (4.5mg/10cm2) Comparing Two Different Formulations

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

AUC(0-tz) of Unconjugated Rotigotine

Cmax of Unconjugated Rotigotine

AUC(0- ∞) of Unconjugated Rotigotine

Secondary outcome:

AUC(0-tz) Norm (Apparent Dose) of Unconjugated Rotigotine

AUC(0-tz) Norm (Body Weight) of Unconjugated Rotigotine

AUC(0- ∞) Norm (Apparent Dose)

AUC(0- ∞) Norm (Body Weight)

Cmax, Norm (Apparent Dose) of Unconjugated Rotigotine

Cmax, Norm (Body Weight) of Unconjugated Rotigotine

Tmax of Unconjugated Rotigotine

Mean Residence Time (MRT) of Unconjugated Rotigotine

Rate Constant of Elimination (λz) of Unconjugated Rotigotine

Terminal Half-Life (t1/2) of Unconjugated Rotigotine

Apparent Total Body Clearance (CL/f) of Unconjugated Rotigotine

Apparent Dose

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Healthy White, male volunteers between 18 and 55 years of age (inclusive).

- BMI between 19 and 28 kg/m^2 (inclusive)

Exclusion Criteria:

- Previous participation in a clinical study with Rotigotine

- History or current condition of epilepsy and/or seizures

- Known clinically relevant allergy or known/suspected clinically relevant drug

hypersensitivity

- History of significant skin hypersensitivity to adhesives or other transdermal

products or recently unresolved contact dermatitis

- History or present condition of an atopic or eczematous dermatitis, psoriasis, and/or

an active skin disease

- Clinically relevant abnormality in physical examination, ECG, vital signs or safety

laboratory examinations

- Positive HIV, hepatitis B or C test or positive alcohol or drug test

- Relevant hepatic or renal dysfunction

- Intake of medication that might interfere with the test drug within 2 weeks prior to

dosing

Locations and Contacts

Moenchengladbach, NRW, Germany
Additional Information

Product Information

FDA Safety Alerts and Recalls

Starting date: January 2010
Last updated: May 15, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017