None listed
Conditions
Brief summary
The purpose of this study is to understand how well Oxycodone in combination with tocopheryl phosphate mix (TPM), is absorbed through the skin and into the bloodstream, with the use of a patch.
Interventions
The study consists of two test groups.
1. A reservoir patch system containing 1% Tocopheryl Phosphate Mix (TPM) and 5% Oxycodone and;
2. A matrix patch system containing 40mg Tocopheryl Phosphate Mix (TPM) and 200mg Oxycodone.
Subjects will be randomly assigned to receive only one of the above treatments.
Both groups will receive the study drug in their allocated patch form containing 200mg Oxycodone. The 200mg will be divided into two 100mg patches applied to each upper outer thigh region. Th
The study consists of two test groups. 1. A reservoir patch system containing 1% Tocopheryl Phosphate Mix (TPM) and 5% Oxycodone and; 2. A matrix patch system containing 40mg Tocopheryl Phosphate Mix (TPM) and 200mg Oxycodone. Subjects will be randomly assigned to receive only one of the above treatments. Both groups will receive the study drug in their allocated patch form containing 200mg Oxycodone. The 200mg will be divided into two 100mg patches applied to each upper outer thigh region. The patch will remain in place for 23 hours and 30 minutes from the time of application and a new patch applied 30 minutes later. This will occur daily, for 10 days, for all volunteers. The matrix patch is made of a solid film polymer whereas the reservoir patch is made of TPM gel enclosed in a semi-permeable membrane.
Sponsors
Phosphagenics Limited
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
Male
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
- Male and aged 18-49 years (inclusive) - Healthy subjects (healthy defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, 12-lead ECG and clinical laboratory determinations. - Body mass index (BMI) equal or greater than 19 and equal or less than 30kg/m2 - Weight is greater than 50 kg - Adequate venous access in the left or right arm to allow collection of a number of blood samples - Fluent in the English language - Able to provide written informed consent to participate in the study and be willing to comply with the study procedures
Exclusion criteria
- History or evidence of drug or alcohol abuse and/or positive repeat urine/breath results prior to start of the study - Individuals who smoked an average of one or more cigarette or tobacco form (inc. cigars) per month in the last 12 months - current use of central nervous system (CNS) depressants including; other opioids, sedatie/hypnotics, phenothiazines, tranquillisers, skeletal muscle relaxants or sedating antihistamines - use of macrolide antibiotics (eg. erythromyc), azole antifungal agents (eg. ketoconazole) or protease inhibitors (eg. ritanovir) within 30 days of study dosing - evidence of clinically relevant oral, cardiovascular, haematological, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric or skin disorders - history of epilepsy - history of coronary diseases, peripheral vascular diseases, cerebrovascular accident, transient ischaemic attack, uncontrolled hypertension or signs/symptoms of ischaemic heart disease eg. hypertension where blood pressure (BP) is persistently > 140/95 mmHg - Any pre-existing medical conditions predisposing the subject to hypoventilation or hypoxaemia - Known allergy or hypersensitivity to Tegaderm (R) patches or to topical preparations, such as sunscreens - A calculated creatinine clearance (CL) of equal to or less than 85 ml/min - Positive screening test for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen or hepatitis C antibody - Use of any prescription medication during the 14 days prior to study dosing, unless approved by both the principal investigator and the sponsor. If necessary, paracetamol (acetaminophen) may be received for mild analgesia prior to, or during, the study - Use of any over the counter product, herbal product, diet aid, hormone supplement, etc., within 14 days prior to dosing unless approved by both the principal investigator and sponsor - Have participated in a clinical trial or receipt of an experimental therapy within 30 days prior to dosing, other than subjects who undertook the naltrexone challenge successfully as alternates for earlier cohorts of this study - blood donation of greater than 550 ml within 90 days before the first dose administration - have a history of low blood pressure or severe motion sickness eg. hypotension where blood pressure is persistently less than 90/50 mmHg - Consumption of a grapefruit juice within 14 days prior to the first day of study confinement and through to completion of the confinement period - Regularly drink more than four units of alcohol daily or who may have difficulty abstaining from alcohol during the 36 hours prior to dose administration and until completion of blood sampling.
Outcome results
None listed