Bioequivalence Study of Cefixime 400 mg Hard Capsules Versus Cefixime 400 mg Film-Coated Tablets in Healthy Subjects
- Trial ID
- 2023-504011-33-00
- Protocol
- CEFIAIS 01/2022
- Sponsor
- Antibiotice S.A.
Trial statistics
Objectives
The primary objective of this study is to evaluate the **bioequivalence** of a single dose of CEFIXIMA ATB 400 mg hard capsules compared to CEFIXORAL® 400 mg film-coated tablets in healthy subjects. Bioequivalence studies are crucial in determining whether two pharmaceutical products are equivalent in their rate and extent of absorption, which is essential for ensuring therapeutic equivalence and patient safety. This study is conducted in a fasted state to assess the pharmacokinetic parameters of the two formulations.
Participants
The clinical trial involves **healthy subjects** of both genders, with an age range of 18 to 65 years. The sponsor has not provided the total number of participants. The trial population was selected to include individuals who are not part of a vulnerable population. Participants are expected to maintain their usual lifestyle, including diet and physical activity, throughout the study. The sponsor has not disclosed specific inclusion or exclusion criteria for this trial.
Plans and Procedures
The clinical trial is designed as a **randomized**, **double-blind**, and controlled study to evaluate the bioequivalence of two formulations of cefixime in **healthy subjects**. The trial is categorized as a Phase 2 study and is expected to commence recruitment on May 1, 2023, with an estimated completion date of June 30, 2023. The trial involves a single-dose administration under fasted conditions, comparing CEFIXIMA ATB 400 mg hard capsules with CEFIXORAL® 400 mg film-coated tablets.
Participants will undergo a sequence of study visits, beginning with an inclusion visit, which serves as the screening phase to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized to receive one of the study drugs. The trial includes follow-up visits to monitor safety and collect pharmacokinetic data. The end-of-study visit will conclude the participant's involvement, ensuring all necessary data is collected and any adverse events are addressed.
The expected duration of participant involvement is approximately two months, from the initial screening to the end-of-study visit. Conditions that may lead to early termination from the study include non-compliance with study procedures, withdrawal of consent, or the occurrence of significant adverse events. The trial is conducted in accordance with ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants.
Treatment
The clinical trial involves the administration of an **experimental medication**. However, specific details regarding the name, pharmaceutical form, dosage, route, and frequency of administration of the experimental medication are not provided in the available data. The trial documentation does not specify whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. Additionally, there is no information on the maximum daily dose, total dose, or treatment period for the experimental medication.
In this clinical trial, there is no mention of any **non-experimental treatments** such as standard-of-care therapy, placebo, or comparator treatment being used. The data does not provide details on any additional relevant information about drug administration, dosing schedules, or participant compliance monitoring. The absence of these details suggests that the trial documentation may be incomplete or that such information is not applicable to this particular study.
Efficacy
The clinical trial is designed to assess efficacy in a Phase 2 study. The trial is scheduled to begin recruitment on May 1, 2023, with an estimated end date of June 30, 2023. The efficacy assessment will be conducted through a series of planned evaluations, although specific parameters or endpoints for efficacy, such as symptom improvement scores or biomarker levels, are not detailed in the available data. The methods and schedule for measuring, collecting, and analyzing these efficacy parameters are not specified. The trial will adhere to standard clinical trial protocols to ensure the reliability and validity of the efficacy assessments. The trial phase indicates a focus on evaluating the effectiveness of the intervention, but further details on the tools or instruments involved in efficacy assessments are not provided.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Informed consent given by subjects in written form, before the initiation of all other screening procedures; • Caucasian race, male/female; • Age between 18 and 55 years; • Body Mass Index (BMI) between 18.5 and 30 kg/m2; • Non – smokers/light smokers (less than 10 cigarettes / day, anamnestic); • Normal findings in the physical examination at screening; • Normal values for blood pressure and heart rate (SBP=100-140 mmHg, DBP = 60-90 mmHg, HR = 50-90 bpm) measured in supine position after 5 minutes of rest; • Normal/ not clinically significant changes in results of standard 12 – lead ECG at screening; • Normal/ not clinically significant changes in results of hematology, clinical chemistry and urinalysis tests, at screening; • Negative serum beta – HCG in female subjects; • Ability to understand the full nature and purpose of the study, including possible risks and side effects; • The subject is able to swallow the study medication; • Ability to cooperate with the Investigator and to fully comply with study requirements; • Affiliated to a social security system or to health insurance or is a beneficiary.
Exclusion Criteria
- 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
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Romania | Not Recruiting | 01 May 2023 | 28 |
Sites & Investigators
Research sites
Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
CEFIXORAL 400 mg compresse rivestite | Comparator | COMPRESSE RIVESTITE | ORAL | 400 | 1 | PRD710153 |
Cefixima Atb 400mg | Test | HARD CAPSULES | ORAL | 400 | 1 | PRD10219548 |