An open-label, exploratory, randomised, three-period, six-sequence single dose crossover study comparing the safety, tolerability and pharmacokinetic profile of a new and marketed flurbiprofen (8.75 mg) spray in healthy male/female subjects under fasting conditions.
- Conditions
- Ear, nose and throat diseasesSore throat
- Registration Number
- NL-OMON48429
- Lead Sponsor
- Reckitt Benckiser Healthcare (UK) Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
Only subjects to whom all of the following conditions apply will be included:
1. Subject has provided written informed consent.
2. Subject is male or female and aged: * 18 years * 55 years.
3. Subjects with a Body Mass Index (BMI) of * 18.5 and * 30kg/m2.
4. Subject is healthy with no clinically significant abnormal findings as determined by medical history, physical examination, vital signs, laboratory tests and echocardiogram (ECG) at screening.
5. Subjects with normal oral mucosa (score of 0 on the WHO Oral Mucositis Guideline).
6. Female subjects of child bearing potential willing to use a highly effective method of contraception throughout the study.
OR Female subjects who are post-menopausal or permanently sterilised.
7. Subjects who are willing to abstain from food and drinks that contains either caffeine, xanthine, grapefruit (including marmalade and juice) and poppy seeds for 48 hours prior to the first drug administration until the end of the last treatment period.
8. Subjects who are willing to abstain from strenuous exercise for 72 hours prior to the first drug administration until the end of the
last treatment period.
9. Subject is willing to comply with all study procedures and is available for the duration of the study.
Subjects to whom any of the following conditions apply must be excluded:
1. Subject has a current or previous clinically significant medical history, as determined by the Investigator, including, but not limited to cardiovascular, hepatic, renal, respiratory, gastro-intestinal, neurological, metabolic, ear, nose and throat (ENT), dental and psychiatric disorders.
2. Subject has any condition that may currently interfere with the absorption, distribution, metabolism or excretion of drugs.
3. Subject has any taste disorder.
4. Subject has a known history of previous allergy, anaphylactic reactions or intolerance related to treatment with flurbiprofen, ibuprofen or other NSAIDs, codeine or the excipients of the test or reference IMPs.
5. Subject is a current smoker (including e-cigarettes) or ex-smoker who has smoked or used nicotine-containing products within 3 years of screening.
6. Subject has a history of drug or alcohol abuse according to the DSM-IV classification or a positive test for drugs of abuse and/or alcohol at screening.
7. Subject has used prescription or non-prescription drugs, including NSAIDs, vitamins, herbal and dietary supplements (with the exception of the continued use of HRT and contraceptives) in the 14 days (or 5 half-lives of the drug, whichever is longer) before first drug administration.
8. Subject has donated 450 mL (or more) blood, including blood products, or has significant loss of blood in the 90 days prior to screening or at any time during the study, except as required by this protocol.
9. Subject has known human immunodeficiency virus (HIV) positive status, or a positive viral serology screen (Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, HIV tests).
10. Female subject who is pregnant as confirmed by a positive pregnancy test or is lactating.
11. Subject has received an investigational product, or participation in another trial involving a marketed or investigational drug in the 30 days prior to first drug administration.
12. Subject who is an employee at the Clinical Unit or is a partner or first degree relative of the Investigator.
13. Subject fails to satisfy the investigator of fitness to participate for any other reason.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety Endpoints: The safety and local tolerability will be determined by:<br /><br>Changes to the oral mucosa as graded using WHO oral mucositis guidelines.<br /><br>Subject responses to the HSE irritancy questionnaire for each product over time</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Endpoints: The following key PK, and other derived parameters for the<br /><br>test (A and B) and reference Investigational Medicinal Products (IMPs) will be<br /><br>assessed:<br /><br>Cmax - the maximum observed plasma concentration.<br /><br>AUC0-t - the area under plasma concentration curve from administration to last<br /><br>quantifiable concentration at time t.<br /><br>Tmax - the time to maximum observed concentration.<br /><br>AUC0-inf - the AUC extrapolated to infinity.<br /><br>T1/2: elimination half life</p><br>