The objectives of this exploratory study are: * To evaluate the safety and local tolerability of the new flurbiprofen 8.75 mg spray. * To compare the pharmacokinetic profile of the new flurbiprofen 8.75 mg spray to marketed flurbiprofen 8.75 mg…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Ear, nose and throat diseases
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety Endpoints: The safety and local tolerability will be determined by:
Changes to the oral mucosa as graded using WHO oral mucositis guidelines.
Subject responses to the HSE irritancy questionnaire for each product over time
Secondary outcome
Secondary Endpoints: The following key PK, and other derived parameters for the
test (A and B) and reference Investigational Medicinal Products (IMPs) will be
assessed:
Cmax - the maximum observed plasma concentration.
AUC0-t - the area under plasma concentration curve from administration to last
quantifiable concentration at time t.
Tmax - the time to maximum observed concentration.
AUC0-inf - the AUC extrapolated to infinity.
T1/2: elimination half life
Background summary
Reckitt Benckiser (RB) have developed a new flurbiprofen 8.75 mg spray which
aims to provide greater perception of efficacy in the sore throat area.
An exploratory clinical study is required to establish the safety and
tolerability profile of the new flurbiprofen 8.75 mg spray. This clinical study
will include two new flurbiprofen 8.75 mg sprays which have identical
characteristics but differ in flavour, and the marketed flurbiprofen 8.75 mg
spray as a reference product.
In addition to establishing the safety and tolerability profile of the new
flurbiprofen 8.75 mg spray, the clinical study will also include an analysis of
the pharmacokinetic profile of flurbiprofen and an organoleptic assessment to
establish a preferred flavour.
Study objective
The objectives of this exploratory study are:
* To evaluate the safety and local tolerability of the new flurbiprofen 8.75 mg
spray.
* To compare the pharmacokinetic profile of the new flurbiprofen 8.75 mg spray
to marketed flurbiprofen 8.75 mg spray.
* To identify flavour preference of the new flurbiprofen 8.75 mg spray.
Study design
This is an open label, exploratory, randomised, three-period, six-sequence
single dose crossover study.
Intervention
Flurbiprofen 8.75 mg (Mint and Cherry Flavour) spray
Flurbiprofen 8.75 mg (Lemongrass and Ginger) spray
Flurbiprofen 8.75 mg (Mint and Cherry) spray
Study burden and risks
The dosage levels of the study drug are based on a previous clinical trial
conducted by the sponsor. The risk to health at the chosen
dose is limited, but the patients may experience any of the side effects in the
ICF or symptoms that have not been reported before.
Volunteer health is closely monitored during the study to minimize these risks.
If the volunteers experience side effects, the investigator will treat them
where necessary. If new information is available on the safety of the study
medication, the volunteers are informed as soon as possible. The blood
collection procedure is not dangerous.
Dansom Lane -
Hull HU8 7DS
GB
Dansom Lane -
Hull HU8 7DS
GB
Listed location countries
Age
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2018-003175-36-NL |
CCMO | NL67219.056.18 |