Bioequivalence Study of Amoxicillin/Clavulanic Acid Powder for Oral Suspension in Healthy Adults Under Fed Conditions
- Trial ID
- 2023-503233-22-00
- Protocol
- 01-AMO-CLA-BIO-22
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to evaluate the **bioequivalence** of Amoxicillin/Clavulanic acid powder for oral suspension (600 mg/42.9 mg/5 mL) compared to Augmentin ES (600 mg/42.9 mg/5 mL) powder for oral suspension in healthy adult male and female volunteers under fed conditions. This is clinically relevant as establishing bioequivalence ensures that the generic formulation is therapeutically equivalent to the reference product, thereby confirming its safety and efficacy for patient use. No secondary objectives are provided for this study.
Participants
The clinical trial involves a study population comprising **healthy subjects** within the age range of 18 to 65 years. Both male and female participants are included, and the trial does not involve any vulnerable populations. The study is a bioequivalence trial, indicating that the participants are in general good health without any specific medical conditions being targeted. The sponsor has not provided information regarding the total number of participants. Selection criteria for the trial population are not detailed, and there are no specific lifestyle considerations such as diet or physical activity mentioned. The trial does not focus on any particular habits or lifestyle factors, and no significant inclusion or exclusion criteria have been highlighted.
Plans and Procedures
The clinical trial is designed as a **randomized**, open-label, single-dose, two-treatment, two-period, cross-over study. It aims to evaluate the **bioequivalence** of Amoxicillin/Clavulanic acid powder for oral suspension 600 mg/42.9 mg/5 mL compared to Augmentin ES 600 mg/42.9 mg/5 mL powder for oral suspension in healthy adult male and female volunteers under fed conditions. The trial is not applicable to any specific medical condition as it involves healthy subjects. The study is categorized under Phase 2 and is expected to commence recruitment on September 18, 2023, with an estimated end date of October 29, 2023.
Participants will undergo a sequence of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized to receive one of the two treatments in the first period, followed by a washout period, and then crossover to the alternate treatment in the second period. Each treatment period will involve a single-dose administration under fed conditions. The end-of-study visit will occur after the completion of both treatment periods to assess the final outcomes and ensure participant safety.
The expected length of participant involvement is approximately six weeks, encompassing the screening, treatment, and follow-up phases. Conditions that may lead to early termination from the study include adverse events, non-compliance with study procedures, or withdrawal of consent by the participant. The study is structured to ensure rigorous monitoring and adherence to ethical standards throughout its duration.
Treatment
No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is available from the provided data. Consequently, a detailed description of the experimental treatment cannot be provided.
Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Therefore, a description of these elements is not possible based on the current data.
Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. As such, these aspects cannot be detailed in this description.
Efficacy
The clinical trial is designed to assess efficacy in a Phase 2 study. The trial is scheduled to begin recruitment on September 18, 2023, with an estimated end date of October 29, 2023. The efficacy assessment will be conducted using predefined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the available data. The trial will follow a structured timeline to ensure systematic data collection and analysis. The study will adhere to rigorous standards typical of Phase 2 trials, focusing on evaluating the treatment's effectiveness in the target population. The trial's design will incorporate appropriate methodologies to ensure the reliability and validity of the efficacy outcomes.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Healthy males and non-pregnant and no breast-feeding females , ≥ 18 and ≤ 60 years of age and weight more than 50.0 kg (on the day of Informed Consent). Caucasian race.
- Non-smoker or past-smoker (who has stopped smoking at least 6 months before the first dosing).
- Body Mass Index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 inclusive (on the day of screening).
- Subject is available for the whole study and has provided his/her written informed consent.
- Subjects in good health, as determined by screening medical history, physical examination, vital signs assessments (heart rate, systolic and diastolic blood pressure, and body temperature) and 12-lead ECG. Minor deviations outside the reference ranges will be acceptable, if deemed not clinically significant by the Investigator.
- All laboratory screening results within the normal range or deemed clinically insignificant by the Investigator.
- Acceptance of use of highly effective contraceptive measures during the whole study by female subjects of childbearing potential and contraceptive measures during the whole study by male subjects.
- The subject speaks and understands Czech fluently.
Exclusion Criteria
- Acute or chronic diseases and/or clinical finding which may interfere with the aims of the study or with the drug’s safety, tolerability, bioavailability and/or pharmacokinetics of the IMP.
- Existing gastrointestinal diseases, renal or hepatic diseases and/or pathological findings, which might interfere with the drug’s safety, tolerability, absorption and/or pharmacokinetics.
- History or presence of serious clinical illness that can impact the fate of drugs (their absorption and/or distribution and/or metabolism and/or elimination).
- History of severe allergy or allergic reactions to the study drugs or related drugs or any of the excipients.
- Clinically significant illness within 28 days before the first dosing, including major surgery.
- Serious mental disease and/or inability to cooperate with clinical team.
- Orthostatic hypotension in history or during the screening procedure.
- Drug, alcohol (≥ 40 g per day pure ethanol for men or ≥ 20 g per day pure ethanol for women), solvents or caffeine abuse.
- Use of organ-toxic drugs within 90 days before the first dosing (e.g. any drug with a welldefined potential for toxicity to a major organ or system such as chloramphenicol, which may cause bone marrow suppression).
- Use of systemic drugs known to alter hepatic metabolism within 90 days prior to the first dosing.
- Any systemic prescription treatment within 28 days before the first dosing, except hormonal contraceptives or hormone replacement therapy taken without significant changes in dose for 90 days prior to the first dosing.
- Any systemic over-the-counter (OTC) drug treatment and/or vitamins and/or herbal treatment and/or food supplements within 14 days before the first dosing.
- Donation or loss of at least 500 mL of blood within 90 days or donation of plasma or platelets within 14 days before the first dosing.
- Getting a tattoo, body piercing or any cosmetic treatment involving skin penetration within 90 days before the screening unless evaluated by Investigator as non-significant for inclusion in the study.
- Positive results of drugs of abuse in urine at screening and at check-in.
- Positive result of alcohol breath test at screening and at check-in.
- Positive result of urine cotinine test at screening.
- Body temperature is > 36.9 °C at screening and at check-in.
- Sitting blood pressure after a minimum of 5 minutes of rest is out of the range of 90-140 mmHg for systolic BP and/or 60-90 mmHg for diastolic BP and/or heart rate out of the range of 50- 100 bpm during the screening procedure.
- Any significant clinical abnormality, including a positive result of HBsAg and/or HCV and/or HIV test during screening procedure.
- Anaemia, haemoglobin below 120 g/L for women and 130 g/L for men at screening.
- Positive result of blood pregnancy test at screening or positive urine pregnancy test at check-in or breast-feeding or lack of results of pregnancy test.
- State of veins on upper extremities does not allow or complicates blood collection.
- Less than 30 days between exit procedure in previous study and the first dosing in this study.
- Presence or history of atopic eczema.
- Known glucose-galactose malabsorption.
- Estimation of glomerular filtration (GF-MDRD-1) bellow 1 mL/s at the screening.
- Any history of known Augmentin-associated jaundice/hepatic dysfunction.
- Any known active mononucleosis.
- History of previous hypersensitivity reaction to penicillins, cephalosporins or other betalactam antibiotics.
- History of phenylketonuria or a known hypersensitivity to aspartame.
- Subject was vaccinated against COVID-19 less than 14 days before the screening and/or subject plans to be vaccinated against COVID-19 during the study.
- Subjects was hospitalized for COVID-19 related reasons.
- Positive PCR for SARS-CoV-02 or positive antigen test, if required for safety reasons before hospitalization in the study.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Czechia | Not Recruiting | 18 Sept 2023 | 56 |
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 |
|---|---|---|---|---|---|---|
Amoxicillin/Clavulanic acid | Test | ORAL SUSPENSION | ORAL | 642.9 | 1 | PRD10214885 |
Heparin Léčiva Injekční roztok | Other | INJEKČNÍ ROZTOK | INTRAVENOUS | 2.1 | 1 | PRD6653638 |
Augmentin ES, (600 mg + 42,9 mg)/5 ml, proszek do sporządzania zawiesiny doustnej | Comparator | PROSZEK DO SPORZĄDZANIA ZAWIESINY DOUSTNEJ | ORAL | 642.9 | 1 | PRD373726 |