Intervention: Ketoprofen lysine
Trial phase: Phase 3
SMILES: CC(C(=O)O)c1cccc(C(=O)c2ccccc2)c1.NCCCCC(N)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 35
Group description: Single oral administration of Ketoprofen lysine salt 40 mg granules

Ketoprofen: 40 mg KLS granules (corresponding to 25 mg ketoprofen)
Eligibility criteria:
Inclusion Criteria:

Signed Informed Consent Form;
Male and female, from 18 years to 65 years (inclusively);
Subjects who undergo removal of a non-impacted molar tooth within 3 hours before randomization in the study;
Subjects in generally good health (based upon criteria for safe administration of outpatient conscious sedation);
Subjects requesting relief for postoperative pain within 3 h after the tooth extraction (VAS ≥30 mm);
Subjects willing to undergo observation period for up to 9 hours after the tooth extraction;
Ability to complete a 100 mm VAS and a category scale during the observation period (about 9 hours);
Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study;

Contraception (for females): females of child-bearing potential must be using at least one reliable method of contraception, as follows:

hormonal oral, implantable, transdermal, or injectable contraceptives;
a non-hormonal intrauterine device [IUD] or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide; or should have:
a male sexual partner who agrees to use a male condom with spermicide;
a sterile sexual partner.

Exclusion Criteria:

Subjects undergoing extraction of impacted and dystopic teeth, tooth preserving operations, apically positioning flap/vestibuloplasty with free gingival graft from the palate;
Subjects undergoing more than one tooth extraction in the same extraction procedure;
Subjects undergoing dental implantation simultaneously with tooth extraction;
Allergy: ascertained or presumptive hypersensitivity to the active substances (ketoprofen and paracetamol as rescue medication) and/or formulations' ingredients; history of hypersensitivity to drugs (in particular to NSAIDs) or allergic reactions in general, which the Investigator considers may affect the outcome of the study;
Diseases: relevant history of renal, hepatic, cardiovascular, respiratory (including asthma), skin, haematological, endocrine, gastro-enteric and genitourinary tract or neurological and autoimmune diseases, that may interfere with the aim of the study;
Medications: non-steroidal anti-inflammatory drugs (NSAIDS) and other analgesics [in particular ketoprofen, paracetamol and acetylsalicylic acid (ASA)], antihistamines, sedating medications, including herbal and BASs, taken 48 h before surgery;
Investigational drug trials: participation in the evaluation of any drug within 3 months before screening (including the last study procedure);
Relevant history of drug and alcohol abuse.
Positive Pregnancy test in female patients of childbearing potential (including patients in post-menopausal status for less than 2 years).