None listed
Conditions
Brief summary
The purpose of this study is to determine how safe and how well the human body tolerates transdermally delivered oxycodone combined with our patented technology (gel) in different patch forms. We would also like to see how much of the final product reaches the bloodstream after transdermal application.
Interventions
The study consists of three test groups.
1. A gel mixture containing of 1% Tocopheryl Phosphate Mix (TPM) and 5% Oxycodone;
2. A reservoir patch system containing 1% Tocopheryl Phosphate Mix (TPM) and 5% Oxycodone and;
3. 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 (or comparator) treatments.
Those allocated to the above groups will receive a total of 200mg Oxycodone applied topicall
The study consists of three test groups. 1. A gel mixture containing of 1% Tocopheryl Phosphate Mix (TPM) and 5% Oxycodone; 2. A reservoir patch system containing 1% Tocopheryl Phosphate Mix (TPM) and 5% Oxycodone and; 3. 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 (or comparator) treatments. Those allocated to the above groups will receive a total of 200mg Oxycodone applied topically to the upper thigh area once for a 72 hour period. 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
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
- Body Mass Index (BMI) must be greater than or equal to 19 and less than or equal to 30 kg/m2. - Weight must be greater than 50kg
Exclusion criteria
History or evidence of drug and/or alcohol abuse; smokers; use of central nervous system (CNS) depressants, other opioids, sedative/hypnotics, phenothiazines, tranquillisers, skeletal muscle relaxants or sedating antihistamines; use of macrolide antibiotics (e.g., Erythromycin), azole antifungal agents (e.g., Ketoconazole) or protease inhibitors (e.g., 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, coronary disease, peripheral vascular diseases, cerebrovascular accident, transient ischaemic attack; uncontrolled hypertension or signs/symptoms of ischaemic heart disease; Any pre-existing medical conditions predisposing the subject to hypoventilation or hypoxaemia; Known allergy or hypersensitivity reactions to naltrexone or to oxycodone, or other opioid analgesics (codeine, fentanyl, hydrocodone, morphine etc.), or allergy to any contents of the gel (i.e., disodium tocopheryl phosphate (TP), sodium di-tocopheryl phosphate (T2P), pemulen gel, triethanolamine, methylparaben); Known allergy or hypersensitivity to lidocaine or Tegaderm(registered trademark) patches or to topical preparations, such as sunscreens; A calculated creatinine clearance (CL) of < 85ml/min; Positive screening test for Human Immunodeficiency Virus (HIV) antibodies, Hepatitis B surface antigen or Hepatitis C antibody; Have a history of low blood pressure (BP) or severe motion sickness e.g., hypotension where BP is persistently < 90/50 mmHg; Consumption of grapefruit or grapefruit juice within 14 days prior to the first day of study confinement and through to completion of the confinement period.
Outcome results
None listed