An open label, balanced, randomized, two-treatment, two-sequence, two-period, cross-over, single-dose, oral bioequivalence study of Abacavir, Dolutegravir and Lamivudine Tablets for Oral Suspension 60mg/5mg/30mg (1 Ã? 5 Tablets) (Test) of Aurobindo Pharma Limited, India with Dolutegravir (GSK1349572)/Abacavir/Lamivudine Dispersible Tablets 5 mg/60 mg/30 mg (1 Ã? 5 Tablets) (Reference) of ViiV Healthcare, UK in 54 healthy, adult, male subjects under fasting conditions

开始日期2022-02-14

申办/合作机构

AXIS Clinicals Ltd.

CTRI/2022/02/040129 / Not yet recruiting临床1期

开始日期2022-02-14

申办/合作机构

AXIS Clinicals Ltd.

CTRI/2022/01/039264 / Recruiting临床3期

A Phase 3, Randomized, Double-Blind, Parallel Group, Multicenter Study to Compare Efficacy, Safety, Pharmacokinetics, and Immunogenicity of BP05 Versus EU-Approved Lucentis® in Patients with Wet (Neovascular)Age-Related Macular Degeneration.

开始日期2022-01-10

申办/合作机构

Curateq Biologics Pvt Ltd.

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2021-03-30·Biosciences Biotechnology Research Asia

Isolation of Fluoride Resistant Microorganisms from Fluoride Contaminated Ground Water Samples of Nalgonda District and their role in Bioremediation

作者: Sultanpuram, Vishnuvardhan Reddy ; Mothe, Thirumala ; Umashankar, Patnam

Consuming of water contaminated with high fluoride concentration for a very long time causes health problems such as, dental and skeletal fluorosis. Hence, defluoridation of water is essentially required before consumption, when water is contaminated with high fluoride concentration. In this present study, research was focussed on to isolate bacteria which are showing fluoride resistantance from samples of ground water from high fluoride affected regions of Nalgonda. After analysis of 10 samples from different areas of Nalgonda district, two samples of ground water from Narketpally and Nampally showed the high fluoride concentrations of 9.18 ppm and 7.55 ppm respectively. Hence, in the present study, Narketpally ground water sample with highest ppm was considered to isolate fluoride resistant bacteria. A total of eight fluoride resistant organisms were purified from this sample with varying fluoride resistance on Luria Bertani agar with varying fluoride concentraion from 25mg/L to 600mg/L at pH 7. Among the eight strains isolated, three strains MB1, F and G were showing high fluoride resistance (up to 500mg/L), which were further explored for their role in bioremediation of fluoride. In batch mode study, MB1 strain showed high fluoride degradation of 68%, whereas, F and G strains showed 57% and 44%fluoride removal, respectively, when fluoride concentration was present at 20 mgL-1 at 30 °C temperature and pH 7, with dextrose (10 g) utilised as source of carbon per 100 mL media after incubation of 8 days. Results indicate that, MB1 possibly a potential fluoride resistant bacterium with high fluoride bioremediation capacity.

2017-06-14·Current Pharmaceutical Analysis

Qualification and Application of a Liquid Chromatography-Tandem Mass Spectrometric Method for the Simultaneous Quantification of Triflusal and its Active Metabolite Desacetyl Triflusal in Human Plasma Using Solid Phase Extraction Technique

作者: Kumar Valluru, Rajani ; Babu Munaga, Sathish ; Bhushana Reddy Bonga, Phani ; Sumathi Rao, V. ; Kumar Sharma, Hemanth

Background: Triflusal and Desacetyl Triflusal prevents the formation of blood clots by inhibiting the enzyme cyclooxygenase, and reducing production of thromboxane A2 which is a stimulator of platelet aggregation and thereby reduces the risk of strokes, heart attacks or other serious circulatory problems.Introduction: A rapid, sensitive, specific, accurate, isocratic reversed-phase liquid chromatog. coupled with triple quadrapole mass spectrometry method in its tandem operation mode was developed and validated for the simultaneous quantification of Triflusal and Desacetyl Triflusal, in human plasma.Method: Salicylic Acid and Hydrochlorothiazide are used as internal standardsThe analytes were extracted from human plasma samples by solid-phase extraction technique using a Strata-X 33μm polymeric sorbent.The reconstituted samples were chromatographed on an Oyster ODS3 100 x 4.6mm, 5μ column using a mobile phase composed of acetonitrile 40:60 (volume/volume) - 2mM ammonium acetate solutions (pH 3.25 A± 0.3) at a flow rate of 3.2 mL/min.The detection of precursor and product ions of analytes and their internal standards was performed by multiple reaction monitoring mode via a turbo ion spray interface in neg. mode by MDS SCIEX API-3000.Result: The calibration curves obtained were linear over the concentration range of 0.100 to 35.086μg/mL for Triflusal, 1.00 to 120.06μg/mL for Desacetyl Triflusal with a correlation coefficient r ≥ 0.9952.The results of the intra- and inter-day precision and accuracy studies were well within the acceptable limits.The intra and inter batch precision was ≤ 12.7 for Triflusal and Desacetyl Triflusal with accuracy (%RE) between -6.6 and 6.9.Stability testing showed that all analytes were stable in plasma at 25 A°C for 17.83 h, seven freeze-thaw cycles, and at -70A°C for 53.65 days.The anal. method was successfully applied to an in vivo study evaluating the pharmacokinetics of Triflusal and Desacetyl Triflusal following single dose oral administration in 24 healthy volunteers in an open label, twoperiod, two sequence, randomized, crossover protocol under fasting conditions.Conclusion: Based on the 90% confidence interval of the individual ratios for Cmax and AUC0-inf, it was concluded that the method is efficient with a very short running time of 3.2min, sufficiently sensitive and suitable for pharmacokinetic studies.

2013-07-01·Journal of Chromatography B3区 · 医学

High throughput LC–MS/MS method for simultaneous determination of tenofovir, lamivudine and nevirapine in human plasma

3区 · 医学

Article

作者: Praveen Kumar ; Phani Bhushana Reddy B ; Naveen Babu Kilaru ; Kalyan Sumanth S ; Rajani Kumar Valluru

A selective and high throughput liquid chromatography-mass spectrometry method has been developed and validated for the simultaneous quantification of tenofovir (TFV), lamivudine (3TC) and nevirapine (NVP) in human plasma using emtricitabine (FTC) as internal standard (ISTD). Following solid phase extraction (SPE), the analytes and ISTD were run on Prontosil C18AQ column (100mm×4.6mm, 3μm) using an isocratic mobile phase consisting of 1mM ammonium acetate in water (pH 6.5±0.3):acetonitrile (50:50, v/v). The precursor and product ions of the drugs were monitored on a triple quadrupole instrument operated in the negative ionization mode. The method was validated over a concentration range of 2-500ng/mL for TFV and over a concentration range of 10-4000ng/mL for 3TC and NVP with relative recoveries ranging from 61 to 85%. The intra and inter batch precision (%CV) across four validation runs was less than 12.2%. The accuracy determined at four QC levels (LLOQ, LQC, MQC and HQC) was within ±8.5%, in terms of relative error.

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