Pharmacokinetic interaction of Diabecon (D-400) with rifampicin and nifedipine.

In the present study, Diabecon (D-400), a herbomineral anti-diabetic preparation, was studied for its pharmacokinetic interaction with the commonly used drugs rifampicin and nifedipine. Interaction of Diabecon with rifampicin: The pharmacokinetic interaction of rifampicin and Diabecon (D-400) was studied in animal models as well as in healthy human volunteers. Twelve rabbits were divided into two groups of six each. Animals in group I were treated with rifampicin (100 mg/kg body weight, p.o.) and group II with rifampicin (100 mg/kg body weight, p.o.) and Diabecon (D-400) (1 g/kg body weight, p.o.) for a period of 8 days. Rifampicin levels in plasma were estimated on day 1 and day 8 at 2, 4, 6 and 8 h after drug administration. On the basis of these findings, a clinical study in 9 healthy human volunteers aged 25-35 years and weighing 50-75 kg was initiated. They were given 450 mg of rifampicin once only on day 1 and from the second day onwards were given 2 tablets of Diabecon (D-400) twice daily for 7 days. On day 9, another dose of rifampicin (450 mg) was given along with 2 tablets of Diabecon (D-400). Blood samples were collected at 2, 4, 6 and 8 h after drug administration on day 1 and day 9 to estimate the rifampicin levels in plasma. Interaction of Diabecon with nifedipine: In another study, 12 rabbits were divided into two groups of 6 each. Group I animals were treated with nifedipine (2.5 mg/kg body weight, p.o.) and Group II animals were treated with nifedipine (2.5 mg/kg body weight, p.o.) and Diabecon (D-400) (1 g/kg body weight, p.o.) for a period of 8 days. On day 1 and day 8, blood samples were collected at 1, 2, 4 and 6 h after drug administration and plasma nifedipine levels were estimated. The results of these three studies revealed that Diabecon (D-400) did not alter the pharmacokinetic profiles of rifampicin and nifedipine.