| Clinical Pharmacology |
1. Bioequivalence of Two Formulations of Enoxaparin 20 mg SC Injection in Normal, Healthy, Male, Human Volunteers JC Shobha Objective : To study the bioequivalence of two formulations of Enoxaparin 20 mg subcutaneous injection in normal healthy, male, human volunteers. Material and Methods : Twelve normal, healthy male human volunteers after fulfilling the inclusion and exclusion criteria entered into the study, after giving their written informed consent. This study was approved by the Ethics Committee of our Institute. After an overnight fast, on the day of the study each volunteer was given subcutaneous injection of 20 mg of enoxaparin of either formulation as per randomization. 5 ml of Blood was collected at 0.0 (pre-dose) and 2.0, 4.0, 6.0, 8.0, and 12.0 hours post dose. Crossover was done after 10 days washout period. Occurrence of any side effects was recorded during the study period. Results : The mean age of the volunteers was 29.6 ± 4.6 years, mean height was 162.0 ± 7.5 cms and the mean weight was 64.0 ± 9.8 Kgs. Anti – Xa acitivity of enoxaparin was measured using STACLOT HEPARIN by anti – Xa method obtained from Diagnostica Stago. The peak anti – Xa activity (C max) was 0.36 ± 0.19 IU/ml with test and 0.32 ± 0.05 IU/ml with reference formulations respectively. The mean time to reach peak concentration (T max) 3.0 ± 1.04 hours with reference and 2.33 ± 0.78 hours with test formulation. The mean area under the time concentration (AUC) curve calculated upto 0-α with reference was 2.53 ± 0.79 IU/hr/ml and 2.38 ± 0.54 IU/hr/ml with test formulation. There was no statistically significant difference in any of these parameters. All the volunteers tolerated both the formulations without any significant adverse effects. Conclusions : The anti-Xa activity was comparable between reference and test formulations. Bioavailability of test formulation was 94% as compared to standard. Drug was tolerated well without any serious side effects. With these findings it can be said that both the formulations are bioequivalent. 2. A Comparative Study on Effect of Policosanol v/s Atorvastin on Lipid Profile in Cases of Hyperlipidemia PD Khandelwal, DD Deol, S Kumar The present study included 50 patients who were put on atorvastatin and 50 patients on policosanol after recording their parameters on designed proforma and baseline blood samples for lipid estimation were taken. The drugs was continued for six weeks and lipid profile was again estimated at the end of six weeks, the patients were crossed over in a double blind manner to complete the study. The atorvastatin therapy lowered mean total cholesterol significantly by 23.24 ± 5.48 (p < 0.05) and with policosanol therapy the reduction was 16.77 ± 6.58 also statistically significant (p < 0.05). Similarly LDL cholesterol reduction was equally significant (p < 0.05) in both groups. The reduction in the TGs was also similar but increase in HDL cholesterol was more significant (p < 0.05) in policosanol group. The overall compliance to policosanol group was found to be excellent. Therefore it is concluded that both drugs are equally effective but policosanol was more patient friendly. |