Search Results - "Kothare, Prajakti A."

Effects of Once-Weekly Dosing of a Long-Acting Release Formulation of Exenatide on Glucose Control and Body Weight in Subjects With Type 2 Diabetes by Kim, Dennis, MacConell, Leigh, Zhuang, Dongliang, Kothare, Prajakti A, Trautmann, Michael, Fineman, Mark, Taylor, Kristin

“…OBJECTIVE:--In patients with type 2 diabetes, exenatide reduces A1C, postprandial and fasting glucose, and weight. In this study we investigated the effects of…”
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Pitavastatin is a more sensitive and selective organic anion‐transporting polypeptide 1B clinical probe than rosuvastatin by Prueksaritanont, Thomayant, Chu, Xiaoyan, Evers, Raymond, Klopfer, Stephanie O., Caro, Luzelena, Kothare, Prajakti A., Dempsey, Cynthia, Rasmussen, Scott, Houle, Robert, Chan, Grace, Cai, Xiaoxin, Valesky, Robert, Fraser, Iain P., Stoch, S. Aubrey

“…Aims Rosuvastatin and pitavastatin have been proposed as probe substrates for the organic anion‐transporting polypeptide (OATP) 1B, but clinical data on their…”
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Effect of renal impairment on the pharmacokinetics of exenatide by Linnebjerg, Helle, Kothare, Prajakti A., Park, Soomin, Mace, Kenneth, Reddy, Shobha, Mitchell, Malcolm, Lins, Robert

“…What is already known about this subject • Nonclinical studies have shown that exenatide is primarily cleared by the renal system. • It was not known to what…”
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Effect of exenatide on gastric emptying and relationship to postprandial glycemia in type 2 diabetes by Linnebjerg, Helle, Park, Soomin, Kothare, Prajakti A., Trautmann, Michael E., Mace, Kenneth, Fineman, Mark, Wilding, Ian, Nauck, Michael, Horowitz, Michael

“…To evaluate the effect of exenatide on gastric emptying (GE) in type 2 diabetes using scintigraphy. Seventeen subjects with type 2 diabetes participated in a…”
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Making Better Dose Decisions: Using Exposure‐Response Modeling to Integrate Efficacy Outcome of Two Phase IIb Clinical Trials of Ubrogepant for Migraine Treatment by Li, Chi‐Chung, Voss, Tiffini, Kowalski, Ken, Yang, Bei, Kleijn, Huub Jan, Jones, Christopher J., Bosch, Rolien, Michelson, David, DeAngelis, Matthew, Xu, Yang, Xie, Iris, Kothare, Prajakti A.

“…Ubrogepant (MK‐1602) is a novel, oral, calcitonin gene‐related peptide receptor antagonist in clinical development with positive phase III outcomes for acute…”
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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Exenatide Once Weekly in Japanese Patients with Type 2 Diabetes by IWAMOTO, Kazuya, NASU, Risa, YAMAMURA, Ayuko, KOTHARE, Prajakti A., MACE, Kenneth, WOLKA, Anne M., LINNEBJERG, Helle

“…This randomized, placebo-controlled, double-blind, parallel study assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of exenatide once…”
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Effect of Exenatide on the Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy Asian Men by Soon, Danny, Kothare, Prajakti A., Linnebjerg, Helle, Park, Soomin, Yuen, Eunice, Mace, Kenneth F., Wise, Stephen D.

“…Exenatide, a treatment for type 2 diabetes, slows gastric emptying as part of its pharmacologic action and may alter the absorption of concomitant oral drugs…”
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Can Digital Health Enable Higher Quality Real‐World Evidence‐Based Decisions? by Dickmann, Leslie J., Kothare, Prajakti A.

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Harnessing the Potential of Emerging Digital Health and Biological Sampling Technologies for Clinical Drug Development: Promise to Reality by Kothare, Prajakti A., Jadhav, Pravin R., Gupta, Pankaj, Harrelson, Jane Croft, Dickmann, Leslie

“…Advances in emerging innovative technologies have led to optimistic outlooks on their transformative potential for healthcare and clinical trials.1 Given the…”
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Effect of Exenatide on the Steady-State Pharmacokinetics of Digoxin by Kothare, Prajakti A., Soon, Danny K. W., Linnebjerg, Helle, Park, Soomin, Chan, Clark, Yeo, Adeline, Lim, Maggie, Mace, Kenneth F., Wise, Stephen D.

“…This open‐label study investigated the effect of exenatide coadministration on the steady‐state plasma pharmacokinetics of digoxin. A total of 21 healthy male…”
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An Integrated Strategy for Implementation of Dried Blood Spots in Clinical Development Programs by Kothare, Prajakti A., Bateman, Kevin P., Dockendorf, Marissa, Stone, Julie, Xu, Yang, Woolf, Eric, Shipley, Lisa A.

“…Dried blood spot (DBS) sample collection has gained increased interest across the pharmaceutical industry as a potential alternative to plasma for…”
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Population PK Analyses of Ubrogepant (MK‐1602), a CGRP Receptor Antagonist: Enriching In‐Clinic Plasma PK Sampling With Outpatient Dried Blood Spot Sampling by Li, Chi‐Chung, Dockendorf, Marissa, Kowalski, Ken, Yang, Bei, Xu, Yang, Xie, Iris, Kleijn, Huub Jan, Bosch, Rolien, Jones, Christopher, Thornton, Bob, Marcantonio, Eugene E., Voss, Tiffini, Bateman, Kevin P., Kothare, Prajakti A.

“…Merck & Co., Inc. (Kenilworth, New Jersey) has recently published an integrated strategy for implementation of dried blood spots (DBS) in late‐stage trials for…”
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Leveraging Digital Health Technologies and Outpatient Sampling in Clinical Drug Development: A Phase I Exploratory Study by Dockendorf, Marissa F., Murthy, Gowri, Bateman, Kevin P., Kothare, Prajakti A., Anderson, Melanie, Xie, Iris, Sachs, Jeffrey R., Burlage, Rubi, Goldman, Andra, Moyer, Matthew, Shah, Jyoti K., Ruba, Rachel, Shipley, Lisa, Harrelson, Jane

“…Merck & Co, Inc (Kenilworth, NJ) is investing in approaches to enrich clinical trial data and augment decision making through use of digital health…”
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D2 Receptor Occupancy of Olanzapine Pamoate Depot Using Positron Emission Tomography : An Open-label Study in Patients with Schizophrenia by MAMO, David, KAPUR, Shitij, KESHAVAN, Matcheri, LARUELLE, Marc, TAYLOR, Cindy C, KOTHARE, Prajakti A, BARSOUM, Penny, MCDONNELL, David

“…A long-acting depot formulation of olanzapine that sustains plasma olanzapine concentrations for over a month after a single injection is currently under…”
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Intestinal Metabolism: The Role of Enzyme Localization in Phenol Metabolite Kinetics by KOTHARE, Prajakti A, ZIMMERMAN, Cheryl L

“…The influence of enzyme localization and blood flow on intestinal elimination was evaluated in rats. Phenol was administered vascularly (∼1400 and 2500 μg)…”
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Effects of atomoxetine on the QT interval in healthy CYP2D6 poor metabolizers by Loghin, Corina, Haber, Harry, Beasley, Charles M., Kothare, Prajakti A., Kauffman, Lynnette, April, John, Jin, Ling, Allen, Albert J., Mitchell, Malcolm I.

“…Aim The effects of atomoxetine (20 and 60 mg twice daily), 400 mg moxifloxacin and placebo on QTc in 131 healthy CYP2D6 poor metabolizer males were compared…”
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Pharmacokinetics, Pharmacodynamics, Tolerability, and Safety of Exenatide in Japanese Patients With Type 2 Diabetes Mellitus by Kothare, Prajakti A., Linnebjerg, Helle, Isaka, Yoshitaka, Uenaka, Kazunori, Yamamura, Ayuko, Yeo, Kwee Poo, de la Peña, Amparo, Teng, Choo Hua, Mace, Kenneth, Fineman, Mark, Shigeta, Hirofumi, Sakata, Yukikuni, Irie, Shin

“…In this single‐blind, parallel, placebo‐controlled study, the pharmacokinetics, pharmacodynamics, tolerability, and safety of subcutaneous exenatide were…”
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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Exenatide Once Weekly in Japanese Patients with Type 2 Diabetes by KAZUYA IWAMOTO, RISA NASU, AYUKO YAMAMURA, PRAJAKTI A.KOTHARE, KENNETH MACE, ANNE M.WOLKA, HELLE LINNEBJERG

“…This randomized, placebo-controlled, double-blind, parallel study assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of exenatide once…”
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The intestinal uptake of phenol from micellar systems does not conform to the aqueous transfer model by KOTHARE, P. A, ZIMMERMAN, C. L

“…To evaluate the aqueous transfer model as the mechanism for the micelle-mediated uptake of phenol in the rat in situ intestinal perfusion model. Phenol in…”
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Effect of exenatide on the pharmacokinetics of a combination oral contraceptive in healthy women: an open-label, randomised, crossover trial by Kothare, Prajakti A, Seger, Mary E, Northrup, Justin, Mace, Kenneth, Mitchell, Malcolm I, Linnebjerg, Helle

“…Consistent with its effect on gastric emptying, exenatide, an injectable treatment for type 2 diabetes, may slow the absorption rate of concomitantly…”
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