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drcampos ★ Brazil, 2007-09-19 23:01 (6859 d 05:59 ago) Posting: # 1095 Views: 6,122 |
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Dear All, I would like to know your opinion about this issue: In my country (Brazil), it has authorized the market of metformin 500mg modified release (glifage XR 500mg. So, I would like to design a study to application of a new formulation: metformin 1000mg modified release (MR). The brazilian guidance about new dosages and formulations (RDC 136/03) is so confused. So, my question is: Is the most adequate study (relative bioavailability) a study 2x2 comparing 1000mg MR versus 2 x 500mg MR (single dose) or a study 2x2 comparing 1000mg MR (single dose) versus 500mg - immediate release taken at time 0h and 12h (with sample colletions until 24h)? I would like to know international regulations about this topic too. Any comments about this topic will be very important to me. Regards, Daniel Rossi de Campos |
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Helmut ★★★   Vienna, Austria, 2007-09-20 18:33 (6858 d 10:27 ago) @ drcampos Posting: # 1101 Views: 5,298 |
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Dear Daniel! ❝ I would like to know your opinion about this issue: In my country ❝ (Brazil), it has authorized the market of metformin 500mg modified release ❝ (glifage XR 500mg. So, I would like to design a study to application of a ❝ new formulation: metformin 1000mg modified release (MR). The brazilian ❝ guidance about new dosages and formulations (RDC 136/03) is so confused. I linked the document for people knowing Portuguese. ❝ Is the most adequate study (relative bioavailability) a study 2x2 ❝ comparing 1000mg MR versus 2 x 500mg MR (single dose) or a study 2x2 ❝ comparing 1000mg MR (single dose) versus 500mg - immediate release taken ❝ at time 0h and 12h (with sample colletions until 24h)? Since the labeling in Germany of Glucophage (Merck) allows the substitution of 2×500mg with 1×1000mg, I would go with the first design. Labeling in the USA reports bioequivalence for extent of exposure (AUC) of 1×1000mg Glucophage XR to 2×500mg Glucophage (IR, tau=12h). Of course rate is incomparable. I would expect ANVISA to see both rate and extend of BA to be similar; therefore my suggestion. ❝ I would like to know international regulations about this topic too. Maybe Annex 1 to the European Guideline is helpful (metformin shows food effects). — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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drcampos ★ Brazil, 2007-09-20 20:56 (6858 d 08:04 ago) @ Helmut Posting: # 1102 Views: 4,889 |
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Dear Helmut, Thank you for your prompt reply and important commentaries. Best regards, Daniel |
Ing. Helmut Schütz