Single-Dose, Two Treatment, Four-Way Crossover Replicate Design to Assess the Bioequivalence of two Fentanyl Transdermal Delivery Systems MYLAN (25ug/h) and Durogesic Dtrans (25ug/h) in Healthy Volunteers under Naltrexone Block. - N/A
- Conditions
- Potent opioid analgesic indicated for the treatment of chronic pain.MedDRA version: 7 Level: LLT Classification code 10049475
- Registration Number
- EUCTR2005-002935-28-GB
- Lead Sponsor
- Bertek Pharmaceuticals International Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
1.Female subjects
·Must have a negative serum pregnancy test prior to entry into the study
·Must not be breast feeding
·For male subjects with female partners of child-bearing potential or female subjects of child-bearing potential, an adequate form of contraception must be adhered to prior to entry into the study and for a further 3 months after the post-study medical. Adequate contraception is defined as the usage by the female partner of any form of hormonal contraception or intra-uterine device plus usage by at least one of the partners of an additional spermicide-containing barrier method of contraception. The use of a barrier method alone or abstinence is not considered adequate.
·Females of non-child bearing potential must either be surgically sterilised or post-menopausal for at least 2 years.
2.Subject is aged between 18 and 55 years inclusive.
3. Subjects of any racial origin.
4.Subject has given signed informed consent.
5.Male subjects are at least 60kg and female subjects are at least 51kg. Subject has a BMI range of 19-29 m².
6.Subject’s medical history is considered normal, with no clinically significant abnormalities.
7.Subject is considered to be in good health in the opinion of the investigator, as determined by:
- A pre-study physical examination with no clinically significant abnormalities.
- Vital signs within normal ranges.
- An ECG with no clinically significant abnormalities.
8.Subject’s pre-study clinical laboratory findings are within normal range or if outside of the normal range not deemed clinically significant in the opinion of the investigator.
Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range
1.Subject has had a clinically significant illness in the four weeks before screening.
2.Use of prescribed medications or over-the-counter preparations for 14 days prior to dosing, except paracetamol which will be allowed up to 48 hours prior to dosing.
3.Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.
4.Ingestion of any vitamins or herbal medications within 7 days prior to and during the transdermal systems application of each period.
5.Consumption of grapefruit, grapefruit-containing products, oranges and orange-containing products within 7 days of drug administration.
6.Subject has a significant history of drug/solvent abuse, or a positive drugs of abuse test at screening not due to a therapeutic medication.
7.Subject with a history of alcohol abuse or currently drinks in excess of 28 units per week (males) or 21 units per week (females).
8.Subject is unable to refrain from alcohol, caffeine or xanthine containing products from 48 hours prior to the initial transdermal systems application, throughout the sample collection periods and throughout the washout period.
9.Subject is unable to refrain from smoking/tobacco products whilst resident in the Clinical Unit.
10.subject is in the opinion of the investigator not suitable to participate in the study.
11.Subject who has participated in any clinical study with an investigational drug/device within one month prior to the first day of dosing.
12.Subject who has a positive result of HIV screen, Hepatitis B screen or Hepatitis C screen.
13.Subject has a known allergy or hypersensitivity to fentanyl or any other component of the therapeutic transdermal system.
14.Subject has a known allergy or hypersensitivity to naltrexone.
15.Subject has had a serious adverse reaction or significant hypersensitivity to any drug.
16.Subject has donated or lost 450mL or more of blood or plasma within the 28 days prior to initial dose of study medication.
17.Any recent, significant change in dietary or exercise habit.
18.Subjects with skin abnormality or hypersensitivity to adhesive tape.
19.Sensitivity to ondansetron.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method