Bioavailability of Amoxicillin Dissolved in Human Milk
|Healthy||Drug: Human milk-dissolved amoxicillin Drug: Water-dissolved amoxicillin||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Bioavailability of Amoxicillin Dissolved in Human Milk: An Adult Volunteer Study as a First Step Towards Defining Drug Doses for Infants|
- Amoxicillin Plasma Concentrations [ Time Frame: Baseline, 0.25, 0.5, 1, 1.5, 3, 4 and 8 hours after dosing ]Amoxicillin plasma concentrations will be determined by HPLC-MS/MS and the parameters will be compared amongst groups.
|Study Start Date:||June 2011|
|Study Completion Date:||October 2013|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
|Experimental: Healthy Controls||
Drug: Human milk-dissolved amoxicillin
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.Drug: Water-dissolved amoxicillin
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.
As recommended by the Expert Committee on Selection and Use of Essential Medicines, WHO (http://www.who.int/selection_medicines/committees/en/index.html), oral solid formulations are the preferred forms of medicines for children, especially in developing countries, because of relatively inexpensive and less complicated manufacturing, transporting and storage processes. Whereas solid dosage forms are advantageous in these pharmaceutical logistics, administering solid formulations to infants and children is a challenging issue. Dissolving medicines in water may be acceptable, but safety of drinking water for infants in developing countries and water solubility of the drug itself are major concerns. These challenges are exemplified in the treatment of infectious diseases and diarrhea in infants. Commonly used drugs for infants in low income settings include antibiotics such as amoxicillin. Expert sources have suggested that drug administration in breast milk may be effective. However, little data is currently available to support the recommendation to administer medications dissolved in breast milk to infants.
The second stage of the project will use the information obtained from the first stage, combined with pre-existing data, to define a rational dosing schedule of the target drug dissolved in human milk for young children, using population PK modeling and simulation. This is a study in silico.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01435824
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5V1X8|
|Principal Investigator:||Shinya Ito, MD||The Hospital for Sick Children|