Bioequivalence study of two film-coated Metformin tablets

• Research type

  Research Study

• Full title

  Bioequivalence study of two metformin hydrochloride 1000mg film-coated tablets in single dose in healthy volunteers.

• IRAS ID

  111761

• Contact name

  James Ritter

• Sponsor organisation

  Guidotti

• Eudract number

  2012-003422-25

• ISRCTN Number

  n/a

• Research summary

  Metformin is a licensed drug which is very widely used to treat the commonest form of diabetes. Guidotti (the sponsor, a pharmaceutical company based in Pisa, Italy) has developed a generic form intended to be interchangeable with the marketed product. The present proposal will be carried out by Quintiles on their behalf. Its object is to compare Metforalmille 1000 film-coated tablets manufactured by Guidotti with Glucophage©, a branded form of metformin 1000 mg film-coated tablets currently on the market, in order to establish whether the Guidotti medicine is "bioequivalent" to the available product. ("Bioequivalence" is defined by medicine regulators in terms of the exposure to active drug of the body tissues after a dose of each product.) Approximately 35 healthy male or female volunteers, aged 18 -50 years old, will be enrolled. The overall duration for each volunteer is approximately 8 weeks, consisting of a 28 day screening period followed by two residential periods separated by a week or more. A single dose of each product is administered, one during one residential period and one during the other, with blood sampling for measurements of the plasma concentrations of metformin. The two products will be administered in random order, similar to tossing a coin, to decide which is given first and which second. Exposure to active drug is evaluated by comparing mathematically derived parameters calculated from the measured metformin concentrations, primarily the maximum concentration (Cmax) and the area under a plot of plasma concentration versus time, the "area under the curve" (AUC). Cmax and AUC after Guidotti metformin are compared with Cmax and AUC after Glucophage to determine whether the Guidotti medication meets predefined limits (80-125%) that establish bioequivalence. Glucose, insulin and other chemical pathology measurements will also be made for the safety of the volunteers and provide supporting information.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  12/LO/1786

• Date of REC Opinion

  30 Nov 2012

• REC opinion

  Favourable Opinion