Bioavailability of Amoxicillin Dissolved in Human Milk
Condition: Healthy
Intervention: Human milk-dissolved amoxicillin; Water-dissolved amoxicillin
Intervention description: An amoxicillin suspension bottle containing 5 grams of amoxicillin (powder) will be resuspended in 60 ml of breast milk to have 100mL of a 50mg/mL suspension.; An amoxicillin suspension bottle containing 5 grams of amoxicillin (powder) will be resuspended in 60 ml of water to have 100mL of a 50mg/mL suspension.
Intervention MeSH terms: Amoxicillin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants underwent 2 arms in a cross-over design: 1 ) amoxicillin disolved in water; and 2) amoxicillin dissolved in human milk. The order of the 2 arms were randomized.
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: healthy adult volunteers; comparative bioavailability; amoxicillin; breast milk; Amoxicillin Bioavailability in breast milk

Summary:

      The investigators propose to study amoxicillin absorption in a 2-stage program that will
      progressively produce, for the first time, information leading to pediatric pharmacology
      recommendations for the administration to children of amoxicillin dissolved in human milk.
      The investigators study will enroll adult volunteers as number of blood extractions, volume
      of blood required and subject availability, among other issues, generate a number of ethical
      and logistical constraints that make it almost impossible to carry such an intensive sampling
      study in infants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy adult volunteers (>18 and <60 years old)

          2. An approximate 50% of the volunteers will be female

          3. Body mass index (BMI) within 18.5 to 29.9 kg/m2

          4. Healthy according to medical history, vital signs and a brief physical examination as
             determined by the principal investigator/Sub-investigators.

          5. Systolic blood pressure between 100-140 mmHg, inclusive and diastolic blood pressure
             between 60-90 mmHg, inclusive, and heart rate between 50-100 bpm, unless deemed not
             clinically significant by the principal investigator/Sub- investigators.

          6. Capable of giving written informed consent prior to receiving study medication

          7. Smoking is not an exclusion criterion but we will identify smokers.

          8. Female participants will be required to fulfill at least one of the following:

               -  Agree to avoid pregnancy and use medically acceptable method of contraception
                  from at least 30 days prior to the study, during the study, and until 30 days
                  after to the study has ended (last study procedure). Medically acceptable methods
                  of contraception include hormonal patch, implant or injection intrauterine
                  device, or double barrier method (condom with foam or vaginal spermicidal
                  suppository, diaphragm with spermicidal). Complete abstinence alone can be used
                  as a method of contraception. Oral contraceptives prior to the study are
                  acceptable as a method of contraception, but an alternative method of
                  contraception will be required during the study and after the study has ended.

               -  Be surgically sterile for a minimum of 6 months

               -  Post menopausal for a minimum of 1 year.

        Exclusion Criteria:

          1. Known history of any clinically significant hepatic (e.g. hepatic necrosis, jaundice,
             hepatobiliary disease), renal, gastrointestinal (e.g. peptic ulcer), cardiovascular
             (e.g. angina, myocardial infarction), cerebrovascular, pulmonary, endocrine (e.g.
             diabetes, hypophosphatemia), immunological, musculoskeletal (e.g. rhabdomyolysis,
             myopathy), neurological, psychiatric, dermatological, or haematological disease or
             condition

          2. History of any clinically significant illness within 30 days prior to dosing

          3. History of any significant physical or organ abnormality

          4. Known history of:

               -  Alcohol abuse or dependence within one year prior to drug administration

               -  Drug abuse or dependence

               -  Food allergies and/or presence of any dietary restrictions

               -  Severe allergic reactions (e.g. anaphylactic reactions, angioedema)

          5. Participation in another clinical trial or receiving an investigational drug within 30
             days of the study commencement or during the study

          6. Use of any prescription medication within 14 days prior to drug administration (except
             for hormonal contraceptives)

          7. Use of any over the counter medications )including herbal and/or dietary supplements
             and/or teas) within 24 hrs prior to drug administration (except for
             spermicidal/barrier contraceptive products)

          8. Any major surgery within 6 months prior to the start of the study

          9. History of allergy to amoxicillin, beta-lactams or amoxicillin excipients

         10. History of allergy to milk, or severe lactose intolerance

         11. Pregnancy or lactating

         12. Conditions associated with malabsorption

         13. Taking any form of antacids as they may increase the risk of orally transmitted
             viruses from human milk.