Info

1575 + 420.11 2.44 + 0.89 10561.8 ± 3057.45 10980.0 + 3089.05 0.1660 + 0.03 4.29 + 0.75 95.93 ± 1.49

1435 + 299.57 2.73 +1.13 10268.2 + 2448.62 10681.6 + 2479.11 0.1732 + 0.04 4.22 +1.02 96.01+ 0.93

In conclusion, the study demonstrated that the test product, Dialon tablet [Gulf Pharmaceutical Industries (Julphar), U.A.E.], 1000 mg metformin hydrochloride per tablet, is bioequivalent to the reference product, Glucophage tablet (Merck, France) 1000 mg metformin hydrochloride per tablet, as summarized by Tables 1 and 2.

The report was issued in consensus with the ICH guidelines concerning the structure and content of the clinical study reports adopted by EMEA.

2.1. History and Source of Metformin

Metformin is an oral antihyperglycemic drug used in the management of type II diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents.

2.2. Chemistry

The structural formula of metformin is shown below:

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