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Pharmacodynamic evaluation of hypoglycemic effect of Damtab in healthy adult male volunteers

  • Sahu, Pratap Kumar (Sri Jaydev College of Pharmaceutical Sciences) ;
  • Pillai, KK (Department of Pharmacology, Faculty of Pharmacy, Jamia Hamdard (Hamdard University)) ;
  • Saha, Nilanjan (Ranbaxy Clinical Pharmacology Unit) ;
  • Sharma, Manju (Department of Pharmacology, Faculty of Pharmacy, Jamia Hamdard (Hamdard University)) ;
  • Najmi, AK (Department of Pharmacology, Faculty of Pharmacy, Jamia Hamdard (Hamdard University))
  • Published : 2007.06.30

Abstract

The objectives of the study were (1) To evaluate the safety and tolerability of Damtab. (2) To characterize hypoglycemic effect of Damtab, if any. (3) To evaluate insulin sensitivity effect of Damtab, if any. Hypoglycemic effect of Damtab (700 mg and 1,400 mg) were examined. Gliclazide (80 mg) was used as an active control. Placebo was used as control. Breakfast was given, half an hour before dosing whereas lunch, snacks and dinner were given at 6, 10 and 14 h post dose. An oral glucose tolerance test was conducted to calculate the insulin sensitivity index from the values of glucose and insulin during oral glucose tolerance test. Both giclazide 80 mg and Damtab 1,400 mg significantly lowered plasma glucose level up to 6 h. Insulin sensitivity index of Damtab (1,400 mg) was found to be similar to that of placebo. A significant increase in insulin level at 1 h post dose of Damtab (1,400 mg) was observed. Damtab 700 mg shows placebo like effect whereas Damtab 1,400 mg possesses hypoglycemic effect.

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