Objective: In the present investigation antidepressant and antianxiety activities of aqueous leaf extracts of Senna alata (200 mg/Kg) were carried out to establish the species as a potent natural antidepressant and anxiolytic drug. Methods:Antidepressant activity was carried out using forced swim test and tail suspension test. In both these tests, the animals were subjected to external stress that results in alteration of the behavior of animal due to fear.The antianxiety activity of aqueous leaf extracts of S. alata has been studied by the elevated plus-maze test in rats. The mean number of entries and the time spent in the open arm after 45 min of the administration of test drug was noted to determine the antianxiety effect of the test drug. Results:For antidepressant activity administration of test drug (200 mg/Kg) showed a significant decrease in the time spent by the animal in state of depression in both the assays which clearly indicates that the aqueous leaf extracts of S. alata exhibited a strong antidepressant activity similar to that of the control drug (Imipramine).In the antianxiety activity, administration of aqueous leaf extract (200 mg/Kg) of S. alata significantly increased the mean number of entries (2.25±0.98) in the open arm and the time spent in open arm (2.23±0.04) compared to the control group. The activity of the extract was slightly greater than standard drug Diazepam. Conclusion:From the above-presented results, it can be concluded that administration of Senna alata aqueous leaf extracts (200 mg/Kg) showed a considerable decrease in both antidepressant and antianxiety activities in all the test animals and can be used in the replacement of commercially available synthetic drugs in the near future.
Introduction Vildagliptin and metformin are two well-established oral antidiabetics with a complementary mechanism of action. Two new generic products, vildagliptin and its fixed-drug combination (FDC) with metformin, were tested for bioequivalence versus the approved originator reference products (Galvus® and Eucreas®). Methods Three randomized studies with two-treatment, two-period, two-sequence crossover design were conducted in healthy adults. One study evaluated vildagliptin 50 mg tablets as single dose under fasting conditions. Vildagliptin–metformin FDC tablet strengths of 50/850 mg and 50/1000 mg were evaluated in separate studies as single dose under fed conditions, given 30 min after a standardized high-fat, high-calorie breakfast following 10 h overnight fasting. Blood samples for analysis were collected until 24 h after dosing in each study period. Bioequivalence between test ( T ) and reference ( R ) products required 90% confidence interval (CIs) for the geometric least square (LS) mean T / R ratio to be within 80–125% for the pharmacokinetic parameters, maximum plasma concentration ( C max ), and area under the curve (AUC 0– t ). Results The 90% CIs of geometric LS means of T / R ratio for C max and AUC 0– t with vildagliptin tablets of 50 mg were 92.22–103.94% and 99.00–102.66%, respectively; corresponding results with FDC tablets for 50/850 mg tablets were 94.81–115.41% and 95.28–106.00% for vildagliptin and 90.87–101.18% and 90.56–100.09% for metformin; for 50/1000 mg tablets C max and AUC 0– t were 105.56–122.30% and 98.30–107.55%, respectively, for vildagliptin and 92.14–103.73% and 94.60–101.81%, respectively, for metformin. Other parameters such as AUC 0–∞ , time to maximum concentration ( T max ), and terminal half-life ( t 1/2 ) were comparable between test and reference products. Adverse events (AEs), mainly vomiting, were reported without relevant difference between test and reference products in each study. AEs were generally mild and transient. No severe or serious AEs occurred. Conclusions The new generic drug products of vildagliptin and the FDCs of vildagliptin and metformin demonstrated bioequivalence to the approved originator products and are therefore expected to provide similar therapeutic effects.
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