A Phase I, open label, randomised, single dose, two-way crossover study in healthy volunteers to determine the pharmacokinetics of two transdermal oxymorphone patch formulations to promote pain relief.

Phosphagenics Limited0 个研究点目标入组 15 人开始时间: 2014年6月6日最近更新: 2020年1月13日

适应症

试验速览

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•Healthy male subjects, aged 18 to 55 years inclusive, body mass index greater than or equal to 19 and less than or equal to 27 kg/m2, weight >50 kg, free from clinically significant illness or disease, as defined. 3.Free from current, recurrent or history (< 5 years) of a significant dermatological condition or generalized skin disorder.

•* History of coronary disease, peripheral vascular disease, cerebrovascular accident, transient ischaemic attack, uncontrolled hypertension or signs/symptoms of ischaemic heart disease.
•* Have a rested systolic blood pressure of < 90 mmHg or > 160 mmHg and/or diastolic blood pressure of < 50 mmHg or > 95 mmHg or radial pulse rate at rest of < 45 beats per minute (bpm) or > 100 bpm
•* History of obstructive airway disease or any condition that may increase the risk for respiratory depression.
•* History of neurologic conditions or convulsive disorders, severe head injury or increased intracranial pressure.
•* A calculated creatinine clearance of < 85 mL/minute
•* Evidence of clinically significant impairment/disorders.
•* Have undergone surgery or received anaesthetic within 30 days of Day 1.
•* Use of central nervous system depressants within 30 days of Day 1.
•* Use of macrolide antibiotics, azole antifungal agents or protease inhibitors within 30 days of Day 1.
•* Use of any prescription medication, over the counter product, herbal product, diet aid, or hormone supplement, within 14 days of Day 1 and for duration of study.
•* Known intolerance any ingredients in the patch, naltrexone or naloxone.
•* Any tattoos, bruises, scars or skin lesions on the area where the patch is to be applied.
•* Consumption of grapefruit, grapefruit juice or any products containing CYP3A4 inhibitors and inducers within 14 days of Day 1 and through to discharge.

发起方

Phosphagenics Limited