ABSTRACT
AIM OF THE STUDY: To determine the bioequivalence of two marketed ornidazole formulations in healthy volunteers. METHODOLOGY: A single dose relative bioavailability of Ornidazole 1.5 g (3 x 500 mg tablets) of test product (Giro, Panacea Biotec Ltd.) and that of standard reference (Dazolic, Sun Pharmaceutical Industries), was investigated in healthy adult males. A total of 12 subjects wee enrolled in the study and investigations consisted of two treatment phases separated by a washout period of seven days. Both treatment phases were of 12 hours durations each. Blood samples were collected at 0, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 12 hours post-administration of assigned drug product. Appropriate fasting restrictions were employed during both the treatment phases. Drug assay was done using HPTLC method. The statistical significance of difference in pharmacokinetic parameters between preparations was tested using ANOVA. RESULTS: The mean peak plasma concentration (Cmax) of 32.67 +/- 4.45 microg/ml was achieved at 1.54 +/- 0.81 hours following administration of test product as against mean Cmax of 31.55 +/- 5.04 microg/ml at 1.79 +/- 0.89 hours for reference standard. The area under time concentration curve (AUC(0-12)) hours was 261.67 +/- 77 microg/ml hours with reference standard and 265.41 +/- 30.82 microg/ml hours for test product. CONCLUSION: There was no statistically significant difference between the two formulations and the two products
Subject(s)
Adult , Antitrichomonal Agents/pharmacokinetics , Biological Availability , Humans , Male , Ornidazole/pharmacokinetics , Reference Values , Time FactorsABSTRACT
OBJECTIVE: To assess the bioavailability of clonazepam from two brands of 2 mg tablet formulations--Epitril and reference brand. METHODS: A two-way randomised cross-over bioavailability study was carried out in 12 healthy male volunteers. Coded plasma samples were analysed for levels of clonazepam by high performance liquid chromatography (HPLC) method. RESULTS: The mean Cmax, Tmax t1/2 beta and AUC (0-48) for Epitril were: 16.31 +/- 3.07 ng/mL, 1.63 +/- 0.48 h, 46.97 +/- 12.26 h and 207.70 +/- 57.07 ng/ml.h; for reference brand were 19.75 +/- 5.95 ng/mL, 1.42 +/- 0.29 h, 46.88 +/- 11.29 h and 215.70 +/- 50.89 ng/ml.h respectively. These were comparable and the differences were not statistically significant. CONCLUSION: Based on above pharmacokinetic parameters, Epitril was bioequivalent to reference brand.
Subject(s)
Administration, Oral , Adult , Analysis of Variance , Biological Availability , Chemistry, Pharmaceutical , Chromatography, High Pressure Liquid , Clonazepam/administration & dosage , Cross-Over Studies , Humans , Male , Middle Aged , Reference Values , Sensitivity and Specificity , TabletsABSTRACT
Blood sugar levels of normal rats treated with D-400 showed significant reduction (P < 0.05) as compared to control groups. The fall was seen at one month and remained so uptill 3 months. Hyperglycemic response to adrenaline was significantly lowered (P < 0.05) following D-400 treatment. D-400 potentiated the hypoglycemia following tolbutamide treatment. Blood sugar remained persistently low in tolbutamide plus D-400 treated group after 3 and 4 hours (P < 0.05). In the alloxan-induced diabetic rats, a significant lowering of blood and urinary sugar was noticed on day 20, 30 and 40 following treatment with D-400 (P < 0.05). Liver glycogen depletion was significantly inhibited in the D-400 treated group (P < 0.025). D-400 has significantly potentiated (P < 0.05) the hypoglycemic action of insulin in alloxan-induced diabetic rats.
Subject(s)
Alloxan/toxicity , Animals , Blood Glucose/analysis , Body Weight/drug effects , Diabetes Mellitus, Experimental/drug therapy , Epinephrine/toxicity , Fasting , Female , Glycogen/metabolism , Glycosuria/metabolism , Liver/drug effects , Male , Phytotherapy , Plant Extracts/administration & dosage , Rats , Rats, Wistar , Tolbutamide/administration & dosageABSTRACT
Effect of Septilin, an ayurvedic formulation proven to be effective in the therapy of chronic infections, was investigated on the phagocytic system and humoral response in rats and mice. Septilin exhibited significant protection in E. coli-induced abdominal sepsis in normal mice and in Staphylococcus aureus-induced sepsis in neutropenic mice. It significantly reduced the viable E. coli cells when incubated with neutrophils in rats. Septilin stimulated the phagocytic function of the reticuloendothelial system in mice. In normal rats, Septilin enhanced anti-SRBC hemagglutination antibody titre by 5.7-fold and showed significant protection in cyclophosphamide-induced humoral suppression.