Registration Dossier
Registration Dossier
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EC number: 214-230-6 | CAS number: 1115-70-4
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- other: expert statement
- Adequacy of study:
- weight of evidence
- Study period:
- 2016
- Reliability:
- 2 (reliable with restrictions)
- Justification for type of information:
- Expert statement based on data from repeat dose toxicity studies after oral admistration
Data source
Reference
- Reference Type:
- other:
- Title:
- Unnamed
- Year:
- 2 016
Materials and methods
Test material
- Reference substance name:
- Metformin hydrochloride
- EC Number:
- 214-230-6
- EC Name:
- Metformin hydrochloride
- Cas Number:
- 1115-70-4
- Molecular formula:
- C4H11N5.ClH
- IUPAC Name:
- N,N-dimethylimidodicarbonimidic diamide hydrochloride
- Test material form:
- solid: bulk
- Remarks:
- migrated information: powder
Constituent 1
Results and discussion
Applicant's summary and conclusion
- Executive summary:
Absolute bioavailability of metformin hydrochloride given under fasting conditions is approximately 50% to 60%. Maximum serum concentrations are reached within 4-8 hours in patients. After repeated administration no accumulation in plasma was observed. Metformin hydrochloride does not undergo hepatic metabolism nor biliary excretion. After tubular secretion Metformin is excreted unchanged in the urine. Following oral administration, approximately 90% of the absorbed drug is eliminated via the renal route within the first 24 hours, with a plasma elimination half-life of approximately 6.2 hours. In blood, the elimination half-life is approximately 17.6 hours.
References:
Fachinfo (2010). Zusammenfassung der Merkmale des Arzneimittels Glucophage®. Available at:http://www.fachinfo.de/[Last accessed 29/02/2012]
Food and Drug Administration (2008). Label Glucophage®Tablets. Available at:http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020357s031,021202s016lbl.pdf[Last accessed 29/02/2012]
Merck KGaA (2006). Nonclinical overview Glucophage XR 750mg.
Quaile M., Melich D., Jordan H., Nold J., Chism J., Polli J., Smith G., and Rhodes M. (2010). Toxicity and toxicokinetics of metformin in rats. Toxicol Applied Pharmacol 243, 340-47.
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