A Single Dose, Fast State, Bioequivalence Study of CEFIXIMA ATB 400 mg Hard Capsules (Antibiotice S.A.) vs. CEFIXORAL® 400 mg Film Coated Tablets (A. Menarini Industrie Farmaceutiche Riunite s.r.l.)

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• • History of hypersensitivity to the investigational products (cefixime) or to other cephalosporins and/or to the drugs within the same pharmacological/chemical class; type I hypersensitivity reactions to beta – lactams (anaphylactic shock, angioedema); hypersensitivity to any inactive ingredients of the investigated drug; • History of severe allergic or anaphylactic reactions, bronchospasm or bronchial asthma (even without a history of anaphylaxis), DRESS syndrome, Stevens – Johnson syndrome, Lyell syndrome; • history of hypersensitivity to heparine; • Any food allergy, problems of galactose intolerance or glucose-galactose malabsorption, or any restriction that could contraindicate the subject's participation in the study; • Current or recent (within 3 months) gastrointestinal disease or symptoms (chronic diarrhea, inflammatory bowel disease – ulcerative colitis, Crohn’s disease), unresolved gastrointestinal symptoms (vomiting, diarrhea, etc.), hepatic or renal diseases or other conditions known to interfere with the absorption, distribution, metabolism or excretion of drug; • Documented medical history of tuberculosis at screening; • History of Clostridioides difficile infection; • Febrile illness within 4 days before the first dose or acute febrile illness before the first administration; • Known positive human immunodeficiency virus infection, active or chronic hepatitis B virus infection, and/or current hepatitis C virus (HCV) infection; subjects with a history of HCV infection who have achieved a documented sustained virologic response 12 weeks after completion of HCV therapy may be enrolled; • Major gastrointestinal surgery (except for appendectomy); • Relevant history or laboratory or clinical findings indicative of acute or chronic disease (cardiovascular, pulmonary, hematologic, metabolic, endocrinal, immunologic, neurological or psychiatric), that could contraindicate drug products administration or likely to influence study outcomes; • Positive testing for hepatitis B or C, HIV; • creatinine clearance <50 ml/hour; • values of AST, ALT, FAL > 2.5x UNL; • values of total bilirubin > 2.5x UNL; • Administration of any OTC drug, vitamins, or natural food supplements or any prescribed systemic or topical medication (except for topical products without systemic absorption) within the last 14 days or 5 half-lives (whichever is longer) prior to the first administration of the tested drug, except if this will not affect the outcome of the study; • Use within 30 days of dosing of any agent that is known to induce or inhibit rug metabolizing enzymes; • Administration of any antibiotics in the last 90 days prior to administration of study medication; • Vaccination with any vaccine within two weeks prior to screening; • Depot injection or implants of any drug within 3 months prior to administration of study medication; • Alcohol consumption or abuse, history of alcoholism or recovered alcoholics; • Regular smokers who smoke more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period; • History of drug abuse or positive result for drug of abuse screening (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine); • Participation in another clinical trial within the last 6 weeks prior to the first drug administration; • Donation of more than 450 ml blood within the last two months prior to the first drug administration; • Unsuitable veins for repeated venipuncture; • Unwillingness or inability to follow the procedures outlined in the protocol or inability to provide written informed consent; • Institutionalized persons. Additional exclusion criteria for females only: • Use of oral contraceptives; • Positive result for pregnancy testing; • Breast – feeding.
• • Women of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 10 days prior to the first IMP administration and a negative urine pregnancy test on the evening prior to each dose administration. • Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. Acceptable forms of contraception include the following:  Barrier methods containing or used in conjunction with a spermicidal agent, or Surgical sterilization • Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:  Postmenopausal with an absence of menses for at least one (1) year, or  Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or  Total hysterectomy