A Multicentric, Comparative Controlled, Randomized, Parallel-Group, Phase III Study to Evaluate the Safety and Efficacy of FDC Containing Rosuvastatin Calcium and Telmisartan on Mild to Moderate Hypertension in Dyslipidemic Patients.

Start Date20 Jan 2012

Sponsor / Collaborator

Biocon Ltd.

[+1]

CTRI/2012/01/002334

/ CompletedPhase 3

A Multicentric, Comparative Controlled, Open Label, Randomized, Parallel-Group, Phase III Study to Evaluate the Safety and Efficacy of FDC containing Orlistat and Metformin with Metformin alone in Obese Type II Diabetic Patients.

Start Date05 Apr 2011

Sponsor / Collaborator

Biocon Ltd.

[+1]

CTRI/2011/10/002054

/ CompletedPhase 3

A Multicentric, Comparative Controlled, Open Label, Randomized, Parallel-Group, Phase III Study to Evaluate the Safety and Efficacy of FDC containing Montelukast plus Acebrophylline and Montelukast alone in Patients Suffering From Chronic Asthama

Start Date20 Feb 2011

Sponsor / Collaborator

Biocon Ltd.

[+1]

100 Clinical Results associated with Taab Biostudy Services

0 Patents (Medical) associated with Taab Biostudy Services

Literatures (Medical) associated with Taab Biostudy Services

World Journal of Pharmaceutical Research

Evaluation of efficacy of teneligliptin by quantification with active glucagon like peptide-1 (GLP-1) from indian human plasma using novel bioanalytical method in LC-ESI-MS/MS

Author: Pal, Tapan Kumar ; Mandal, Pallab ; Chakraborty, Soumya ; Shaharyar, Adil Md. ; Karmakar, Sanmoy ; Mandal, Avishek ; Sarkar, Arnab ; Bhowmik, Rudranil

Teneligliptin is an inhibitor of DPP-4 enzyme by which treated hyperglycemic patient.The main target of this proteonomic study was to evaluation of the efficacy of teneligliptin on inhibition of DPP-4 enzyme.In previous literature several studies depended on quantifying the concentration of DPP-4 enzyme by ELISA method.But in this study inhibition of DPP-4 enzyme by teneligliptin was evaluated by quantification of the active concentration of Glucagon like peptide-1(GLP-1) by a novel validated LC-MS/MS QTRAP (API-4000) method.Active GLP-1 is an endogenous compound, so before administration of reference preparation, endogenous compound active GLP-1 concentration in human plasma was 31 ± 11 fg/mL and in the case of test preparation 42 ± 11 fg/mL.After treating reference preparation the maximum plasma concentration of active GLP-1 was 330 ± 28.0 fg/mL (Cmax) at 1.05 ± 0.18 h (tmax) and after administration of test product in the fasting state teneligliptin tablet IP 10mg the maximum plasma concentration of active GLP-1 was 141.00 ± 11.00 fg/mL (Cmax) at 1.01 ± 0.00 h (tmax) then decrease its concentration and again increase it to 71.00 ± 5.10 fg/mL at (Cmax)14.01 ± 0.00h (tmax) after administration of a second dose of teneligliptin tablet IP 10mg after 12h of first dosing time of administration.This method is highly selective, sensitive, specific, low ion suppressive, highly recovered, validated according to US-FDA and EMA guidelines, and successfully used for quantifying pharmacokinetic parameters of active concentration of peptide and teneligliptin from Indian healthy human plasma.

Materials Chemistry Frontiers

β-Cyclodextrin based pH and thermo-responsive biopolymeric hydrogel as a dual drug carrier

Author: Maity, Priti Prasanna ; Dhara, Santanu ; Bose, Anirbandeep ; Roy, Arpita ; Pal, Sagar

Herein, a novel biocompatible and stimuli-responsive network gel has been developed by grafting and crosslinking poly(N-isopropyl acrylamide) and poly(methacrylic acid) on cyclic oligosaccharide β-cyclodextrin [β-CD-cl-(PNIPAm-co-PMAc)].

World Journal of Pharmaceutical Research

Evaluation of potentiality of antimicrobial activity of triazapentacyclo piperidine containing broad spectrum antibiotic rifabutin by minimal inhibitory concentration to treat Mycobacterium avium complex infection in HIV patient and quantification of pharmacokinetics parameters in Indian human plasma by liquid chromatography tandem quadruple mass spectrometry (API-4000)

Author: Saha, Chiranjit ; Karmakar, Sanmoy ; Mandal, Pallab ; Chakraborty, Soumya ; Pal, Tapan Kumar ; Chakraborty, Nilendra

Mycobacterium has caused epic diseases: tuberculosis is still the more important infectious killer of humans.Mycobacterium avium-intracellulare (or Mycobacterium avium complex; MAC) continues to be difficult to treat.Rifabutin is an antibiotic used as first line treatment to treat tuberculosis and prevent and treat Mycobacterium avium complex.This derivative of macrocyclic antibiotic rifampin is typically only used in those who cannot tolerate rifampin such as people with HIV/AIDS on antiretroviral and for active tuberculosis it is used with other antimycobacterial medications also used for latent tuberculosis when exposed to drug resistant TB.Rifabutin inhibits the growth of most MAC isolates at concentration ranging from 0.25-1.0mg/L and also inhibit the growth of many strains of M. tuberculosis at concentration of 0.015 to 0.125μg/Ml and it had been reported from Pfizer Mycobutin hard gelatin capsule 150mg that rifabutin in vitro MIC99 values of ≤0.5μg/mL, determined by agar dilution method for Mycobacterium kansasii, Mycobacterium gordonae and Mycobacterium marinum that in case of in in vitro has better MICs than rifampin.Rifabutin (CAS NO.-72559-06-9), is similar in structure and activity of rifampin, which is semi synthetic rifamycin.The chem. name of rifabutin is 1, 4-didehydro-1-deoxy-1-4-dihydro-5-(2-Me propyl)-1-oxorifamycin XIV.Mol. formula of rifabutin is C46H62N4O11, belonging to the class of ansamycins.It is found that rifabutin inhibits DNA-dependent RNA polymerase, which interact with and to penetrate the outer layers of Escherichia coli (E. coli) and Bacillus subtilis.But mammalian cells are not affected.This enzyme did not inhibited by resistant strains of E. coli, rifabutin, like rifampin.Advanced HIV patients are administered rifabutin for prevention of disseminated Mycobacterium avium complex.It is not known how rifabutin inhibits this reaction.Rifabutin also inhibited the DNA synthesis of rifampin resistant Mycobacterium tuberculosis by inhibiting thymidine incorporation into DNA.In the present study efforts were given to develop and validate a bioanal. method for estimation of rifabutin in human plasma by LC-MS/MS (API-4000).The calibration concentrations of rifabutin were 62.5-4000 ng/mL which accuracy was 101.36-106.54%, 100.56-105.79%, 97.73-107.59%, 100.55-108.15% and 97.13-103.42% for freeze thaw, short term, bench top, auto sampler stability and long term stability resp. and recovery was 98.53-99.56%, matrix factor was 0.94-0.96.The developed method used for determination and quantification of pharmacokinetic parameter of rifabutin in human plasma was also validated as per the US-FDA guidelines.The validation parameters found within the specified regulatory limit, hence acceptable.The present method also has a short run time (3.50 min) and easy plasma extraction process by protein precipitation technique.This method was simple, specific, highly selective, sensitive and reproducible.The developed and validated LC-ESI-MS/MS assay method was applied to compare the oral bioavailability of two formulations (test and reference) by conducting the single oral dose, open label, randomized, two period, two sequence, crossover study of 24 healthy Indian volunteers (male) with an average age of 28.08 ± 4.92 years and average BMI of 21.88 ± 1.54Kg/m2 under fasting condition.The pharmacokinetic parameters like Cmax, Tmax, AUC0-t, AUC0-∞, Kel, T1/2 are determined for rifabutin to calculate the relative bioavailability of test preparation rifabutin 150mg tablet over the reference preparation of same dosage after oral administration to healthy human volunteers.In vitro dissolution of reference and test preparation showed that more than 90% drug was released for reference preparation and test preparation after 45 min.In vitro dissolution test of rifabutin showed that after 45 min 93.51 (for reference), and 96.47 (for test) drug released in appropriate test condition.From the study of pharmacokinetic application of rifabutin it was observed that after oral administration of 150mg rifabutin capsule dissolution occurs in 45min. and absorb into the systemic circulation and peak plasma levels were achieved between 2.0-4.0hrs for reference preparation and 1.0-3.0 h for test preparationThe mean peak plasma levels of rifabutin with reference preparation, on the study day ranged between 233.940 - 385.640 ng/mL.While the rifabutin test preparation of ranged between 219.570 - 394.790 ng/mL.The value of pharmacokinetic parameters of rifabutin are Cmax 302.464 ± 41.612 for reference drug and 298.270 ± 56.790 for test drug; Tmax 2.813 ± 0.845 for reference drug and 1.979 ± 0.667 for test drug; AUC0-∞ 1937.949 ± 521.650 for reference drug and 1960.553 ± 445.403 for test drug; Kel 0.0205 ± 0.075 for reference drug and 0.173 ± 0.041 for test drug; T1/2 3.815 ± 1.318 for reference drug and 4.272 ± 1.171 for test drug.On the basis of comparison of the AUC0-t for rifabutin 150 mg capsule after single dose administration, the relative bioavailability of the test preparation of rifabutin 150mg was 100.22% of that of the reference preparationAccording to WHO report the critical concentration (MIC) of rifabutin 500ng/mL and below this concentration rifabutin is highly sensitive.According to WHO report 13% MAC isolates from MAC infected HIV patient after treating by 500ng/mL concentrated rifabutin, so after treating test preparation rifabutin capsule approx. less than 10% MAC will be isolated from MAC infected HIV patient within 1.0-3.0 h.It was concluded that rifabutin 150mg test preparation highly sensitive than reference preparation in case of MAC infected HIV patient.

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