Bioavailability of Amoxicillin Dissolved in Human Milk

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Hospital for Sick Children
• Collaborator: World Health Organization
• Treatments: Amoxicillin

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.