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Your search keyword '"Modi, Nishit B."' showing total 256 results
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256 results on '"Modi, Nishit B."'

2. JNJ-77242113, a highly potent, selective peptide targeting the IL-23 receptor, provides robust IL-23 pathway inhibition upon oral dosing in rats and humans

Author

Fourie, Anne M., Cheng, Xiaoli, Chang, Leon, Greving, Carrie, Li, Xinyi, Knight, Beverly, Polidori, David, Patrick, Aaron, Bains, Trpta, Steele, Ruth, Allen, Samantha J., Patch, Raymond J., Sun, Chengzao, Somani, Sandeep, Bhandari, Ashok, Liu, David, Huie, Keith, Li, Shu, Rodriguez, Michael A., Xue, Xiaohua, Kannan, Arun, Kosoglou, Teddy, Sherlock, Jonathan P., Towne, Jennifer, Holland, M. Claire, and Modi, Nishit B.

Published
2024
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11. Rusfertide for Polycythemia Vera: Similar Dosing in Patients Receiving Therapeutic Phlebotomy Alone or in Combination with Cytoreductive Treatment

Author

Gerds, Aaron T., primary, Gotlib, Jason, additional, Palmer, Jeanne M., additional, Pemmaraju, Naveen, additional, Bose, Prithviraj, additional, Ginzburg, Yelena, additional, Valone, Frank, additional, Modi, Nishit B., additional, Khanna, Sarita, additional, O'Connor, Paula G., additional, Gupta, Suneel K., additional, and Hoffman, Ronald, additional

Published
2022
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12. Verify: A Phase 3 Study of the Hepcidin Mimetic Rusfertide (PTG-300) in Patients with Polycythemia Vera

Author

Verstovsek, Srdan, primary, Kuykendall, Andrew, additional, Hoffman, Ronald, additional, Koschmieder, Steffen, additional, Passamonti, Francesco, additional, Valone, Frank, additional, Modi, Nishit B., additional, Khanna, Sarita, additional, O'Connor, Paula G., additional, Gupta, Suneel K., additional, and Kiladjian, Jean-Jacques, additional

Published
2022
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18. Rusfertide (PTG-300) Induction Therapy Rapidly Achieves Hematocrit Control in Polycythemia Vera Patients without the Need for Therapeutic Phlebotomy

Author

Ginzburg, Yelena, primary, Kirubamoorthy, Kamini, additional, Salleh, Sinari, additional, Lee, Sung-Eun, additional, Lee, Jae Hoon, additional, Selvaratnam, Veena, additional, Gupta, Suneel K, additional, Valone, Frank, additional, Khanna, Sarita, additional, Modi, Nishit B, additional, Hoffman, Ronald, additional, and Chew, Lee Ping, additional

Published
2021
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23. Dapoxetine has no pharmacokinetic or cognitive interactions with ethanol in healthy male volunteers

Author

Modi, Nishit B., Dresser, Mark, Desai, Dhaval, Edgar, Christopher, and Wesnes, Keith

Subjects
ALZA Corp., Alcohol -- Research, Serotonin uptake inhibitors -- Research, Submarine boats -- Research, Alcohol, Denatured -- Research, Sexual disorders -- Research, Pharmaceutical industry -- Research, Health, Research
Abstract

Dapoxetine is being investigated for the treatment of premature ejaculation. This study evaluated the potential pharmacokinetic and cogitive interactions of dapoxetine 60 mg with ethanol 0.5 k/kg in a single-center, [...]

Published
2007

24. Pharmacokinetics of dapoxetine, a new treatment for premature ejaculation: impact of age and effects of a high-fat meal

Author

Dresser, Mark J., Kang, Dongwoo, Staehr, Peter, Gidwani, Shalini, Guo, Cindy, Mulhall, John P., and Modi, Nishit B.

Subjects
Drug interactions -- Research, Premature ejaculation -- Drug therapy -- Research, Anti-impotence agents -- Dosage and administration -- Research, Health, Drug therapy, Research, Dosage and administration
Abstract

Dapoxetine is being developed as a treatment for premature ejaculation and has demonstrated rapid absorption and elimination in previous pharmacokinetic studies. Two open-label studies were conducted in healthy men: a [...]

Published
2006

25. Single- and multiple-dose pharmacokinetics of dapoxetine hydrochloride, a novel agent for the treatment of premature ejaculation

Author

Modi, Nishit B., Dresser, Mark J., Simon, Mary, Lin, Denise, Desai, Dhaval, and Gupta, Suneel

Subjects
Pharmacokinetics -- Research, Serotonin agents -- Research, Premature ejaculation -- Care and treatment -- Research, Health, Care and treatment, Research
Abstract

Dapoxetine is a serotonin transporter inhibitor currently in development for the treatment of premature ejaculation. This randomized, 2-sequence, 2-treatment crossover study assessed the single- and multiple-dose pharmacokinetics of dapoxetine following [...]

Published
2006

26. Pharmacokinetics and pharmacodynamics of warfarin when coadministered with pentosan polysulfate sodium

Author

Modi, Nishit B., Kell, Sherron, Simon, Mary, and Vargas, Ramon

Subjects
Pharmacology -- Research, Warfarin -- Dosage and administration -- Research, Drug interactions -- Research, Health, Research, Dosage and administration
Abstract

The effect of pentosan polysulfate sodium on warfarin pharmacokinetics and pharmacodynamics was investigated in healthy subjects. Warfarin was titrated to an international normalized ratio between 1.4 and 1.8. Subjects continued [...]

Published
2005

42. Onset and duration of effect of extended-release carbidopa-levodopa in advanced Parkinson’s disease

Author

Hauser,Robert A, Ellenbogen,Aaron, Khanna,Sarita, Gupta,Suneel, Modi,Nishit B, Hauser,Robert A, Ellenbogen,Aaron, Khanna,Sarita, Gupta,Suneel, and Modi,Nishit B

Abstract

Robert A Hauser,1 Aaron Ellenbogen,2 Sarita Khanna,3 Suneel Gupta,3 Nishit B Modi3 1Departments of Neurology, Molecular Pharmacology, and Physiology, University of South Florida, Tampa, FL, USA; 2Quest Research Institute, Bingham Farms, MI, USA; 3Impax Laboratories, Inc., Hayward, CA, USA Background: In patients with Parkinson’s disease (PD), oral dosing of extended-release carbidopa-levodopa (Rytary, IPX066 [ER CD-LD]) achieves peak levodopa plasma concentrations within 1 hour and maintains them for 4–6 hours. Aims: To compare the onset and duration of ER CD-LD benefit with those of immediate-release carbidopa-levodopa (IR CD-LD) in PD patients with motor fluctuations, using crossover data, and to evaluate which threshold values of improvement in finger-tapping and Unified Parkinson’s Disease Rating Scale (UPDRS) motor scores yield results most similar to those for trained raters’ “on”/“off” assessments. Methods: Patients underwent serial “on”/“off” rating and provided serial finger-tapping and UPDRS motor scores after receiving, in an “off” state, their usual morning IR dose or an ER dose designed to produce a similar levodopa peak concentration. Predefined improvement thresholds for analysis were 10%, 15%, and 20% increases in finger-tapping score and 2.5, 5, 7, and 11-point decreases in UPDRS motor score. Serial plasma samples were assayed for levodopa. Results: Among 27 patients, mean time to onset of an “on” state was similar for ER compared with IR CD-LD (0.83 vs 0.81 hour), but mean duration was significantly longer for ER CD-LD than for IR CD-LD (5.56 vs 2.69 hours; P<0.0001). Duration was best matched by a ≥20% improvement in finger-tapping, a ≥11-point improvement in UPDRS motor score, and a levodopa plasma concentration ≥1,000 ng/mL. Conclusion: For ER CD-LD, observer a

Published
2018

43. Pharmacokinetics and pharmacodynamic, pharmacokinetic, pharmacodynamic, and electrocardiographic effects of dapoxetine and moxifloxacin compared with placebo in healthy adult male subjects

Author

Modi, Nishit B., Nath, Rajneesh, Staehr, Peter, Gupta, Suneel K., Aquilina, Joseph W., and Rivas, David

Subjects
Men -- Health aspects, Moxifloxacin -- Dosage and administration, Moxifloxacin -- Research, Pharmacokinetics -- Analysis, Premature ejaculation -- Diagnosis, Premature ejaculation -- Care and treatment, Health
Published
2009

50. Pharmacokinetics of Rytary®, An Extended-Release Capsule Formulation of Carbidopa-Levodopa.

Author

Mittur, Aravind, Gupta, Suneel, Modi, Nishit, and Modi, Nishit B

Subjects
PHARMACOKINETICS, CARBIDOPA, PARKINSON'S disease treatment, PHARMACEUTICAL encapsulation, PHARMACODYNAMICS, DISEASE progression, THERAPEUTICS, DRUG therapy for Parkinson's disease, DOPA, ANTIPARKINSONIAN agents, COMBINATION drug therapy, CONTROLLED release preparations, DOSAGE forms of drugs, DOSE-effect relationship in pharmacology, PARKINSON'S disease, DOPAMINE agents
Abstract

Parkinson's disease (PD) is a chronic progressive neurological disorder characterized by resting tremor, rigidity, bradykinesia, gait disturbance, and postural instability. Levodopa, the precursor to dopamine, coadministered with carbidopa or benserazide, aromatic amino acid decarboxylase inhibitors, is the most effective and widely used therapeutic agent in the treatment of PD. With continued levodopa treatment, a majority of patients develop motor complications such as dyskinesia and motor 'on-off' fluctuations, which are, in part, related to the fluctuations in plasma concentrations of levodopa. A new extended-release (ER) carbidopa-levodopa capsule product (also referred to as IPX066) was developed and approved in the US as Rytary® and in the EU as Numient®. The capsule formulation is designed to provide an initial rapid absorption of levodopa comparable to immediate-release (IR) carbidopa-levodopa, and to subsequently provide stable levodopa concentrations with reduced peak-to-trough excursions in plasma concentrations in order to reduce motor fluctuations associated with pulsatile stimulation of dopamine receptors and to minimize dyskinesia. Phase III studies of this ER carbidopa-levodopa capsule formulation in patients with PD have shown a significant reduction in 'off' time compared with IR carbidopa-levodopa and carbidopa-levodopa-entacapone. We present a review of the clinical pharmacokinetics and pharmacodynamics of this ER product of carbidopa-levodopa in healthy subjects and in patients with PD. [ABSTRACT FROM AUTHOR]

Published
2017
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