This trial is completed!
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You can access this
clinical trial
if you have
Diabetes Mellitus, Type II
and you are a man who is
between 18 and 45
years old
Phase
1
This is an early phase trial to determine
the dosage and safety of the new treatment.
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The purpose

To establish the bioequivalence between Acarbose / Metformin FDC (50mg / 500mg) and loose combination of Acarbose (Glucobay) (50mg) and Metformin (Glucophage) (500mg).

Provided treatments

  • Drug: Acarbose/Metformin FDC (BAY81-9783)
  • Drug: Acarbose (Glucobay, BAYG5421)
  • Drug: Metformin
Tris trial is registered with FDA with number: NCT01728740. The sponsor of the trial is Bayer and it is looking for 40 volunteers for the current phase.
Official trial title:
Randomized, Non-blinded Crossover Study to Establish the Bioequivalence Between Fixed Dose Combination (FDC) and Loose Combination of Acarbose and Metformin and to Investigate the Potential for a Drug-drug Interaction Following Single Oral Dosing in Healthy Adult Male Subjects