Sore throat MedDRA version: 12.1 Level: LLT Classification code 10041367 Term: Sore throat
Conditions
Interventions
Product Name: Flurbiprofen 8.75mg Spray
Product Code: Flurbiprofen 8.75mg Spray
Pharmaceutical Form: Oromucosal spray
INN or Proposed INN: Flurbiprofen
CAS Number: 5104-49-4
Concentration unit: mg mil
Sponsors
Celerion
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Only subjects to whom all of the following conditions apply will be included: i) Age: >18 to 20 and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects to whom any of the following conditions apply must be excluded: i) A history of any significant disease of any body system ii) Any condition that may currently interfere with the absorption, distribution, metabolism or excretion of drugs iii) A history of allergy or intolerance (including angio-oedema, urticaria, bronchospasm and rhinitis) related to treatment with Flurbiprofen, ibuprofen or other NSAIDs, codeine or the excipients of the formulations iv) A history of peptic or duodenal ulcers or upper gastro-intestinal bleed, or other significant gastro-intestinal disorders v) A history of frequent dyspepsia, e.g. heartburn or indigestion vi) A history of migraine vii) A history of psychotic illness, attempted suicide or parasuicide. viii) Current smokers and ex-smokers who have smoked within 6 months ix) A history of drug abuse (including alcohol) x) Those with a positive drugs of abuse screen including alcohol on any occasion throughout the study xi) Ingestion of a prescribed drug at any time in the 14 days before dosing with study medication (excluding hormonal contraceptives and hormone replacement therapy) xii) Ingestion of an over-the-counter preparation within 7 days before dosing with study medication xiii) Donation of blood or plasma in quantity e.g. to the Blood Transfusion service in the previous 90 days or donation of bone marrow in the previous 6 months, before enrolment into the study xiv) Known risk factors for AIDS or known HIV positive status, or a positive viral serology screen xv) Those in the opinion of the Investigator with any clinically significant abnormal laboratory values xvi) Woman of childbearing potential, who are pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions, (i.e. an oral or injectable contraceptive, an approved hormonal implant or topical patch, an intrauterine device, abstinence [should the subject become sexually active, she must agree to use a double barrier method] or condoms/diaphragm and spermicide). A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone an hysterectomy or surgical sterilisation, e.g. bilateral tubal ligation, bilateral ovariectomy (oophorectomy) xvii) Those unable in the opinion of the Investigator to comply fully with the study requirements xviii) Those who have been dosed in a clinical trial in the previous 90 days xix) Those previously randomised into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: As the objective of this study is primarily exploratory rather than to meet regulatory requirements, the pharmacokinetic performance of the test products will be assessed using several alternative dimensions. No single pharmacokinetic parameter will be deemed to be the primary study endpoint. ;Secondary Objective: No secondary objectives;Primary end point(s): All of the following endpoints will be assessed, within each treatment group:- • tmax for Flurbiprofen • Cmax for Flurbiprofen • AUC0-t for Flurbiprofen (where t is the last measurable time-point) • AUC0-8 for Flurbiprofen • t1/2 for Flurbiprofen • Kel for Flurbiprofen • plasma Flurbiprofen concentrations at predose, 2, 5, 10, 15, 30, 40, 50, 60, 75, 90, 120, 180, 240, 360, 480 and 720 minutes postdose • partial AUCs for Flurbiprofen at predose, 2, 5, 10, 15, 30, 40, 50 and 60 minutes postdose ;Timepoint(s) of evaluation of this end point: n/a | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: n/a;Secondary end point(s): n/a | — |
Countries
United Kingdom
Outcome results
None listed