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Pharmacokinetic Drug Interaction Between Raloxifene and Cholecalciferol in Healthy Volunteers
Pharmacokinetic Drug Interaction Between Raloxifene and Cholecalciferol in Healthy Volunteers
Abstract Osteoporosis is a common skeletal disorder, often leading to fragility fracture. Combination therapy with raloxif...
Population Pharmacokinetic Modeling and Exposure‐Response Analysis for Aripiprazole Once Monthly in Subjects With Schizophrenia
Population Pharmacokinetic Modeling and Exposure‐Response Analysis for Aripiprazole Once Monthly in Subjects With Schizophrenia
Abstract An intramuscular formulation of aripiprazole monohydrate dosed once monthly (AOM) was developed to address nonadh...
Pharmacokinetics, Bioequivalence, and Safety Studies of Amlodipine Besylate in Healthy Subjects
Pharmacokinetics, Bioequivalence, and Safety Studies of Amlodipine Besylate in Healthy Subjects
Abstract This study aimed to evaluate the bioequivalence of 2 amlodipine besylate tablet formulations, a generic formulati...
Pharmacokinetics and Bioequivalence Studies of Roxatidine Acetate Hydrochloride Sustained‐Release Capsule in Healthy Chinese Subjects
Pharmacokinetics and Bioequivalence Studies of Roxatidine Acetate Hydrochloride Sustained‐Release Capsule in Healthy Chinese Subjects
Abstract This study aimed to evaluate the bioequivalence between a generic roxatidine acetate hydrochloride (RAH) sustaine...
Evaluating the Safety, Tolerability, and Disposition of Trazpiroben, a D2/D3 Receptor Antagonist: Phase I Single‐ and Multiple‐Ascending Dose Studies in Healthy Japanese Participants
Evaluating the Safety, Tolerability, and Disposition of Trazpiroben, a D2/D3 Receptor Antagonist: Phase I Single‐ and Multiple‐Ascending Dose Studies in Healthy Japanese Participants
Abstract Trazpiroben (TAK-906) is a peripherally selective dopamine D2/D3 receptor antagonist being developed to treat chr...
Subcutaneous Atezolizumab: A Jab Without a Benefit
Subcutaneous Atezolizumab: A Jab Without a Benefit
The recent publication by Felip et al1 describing the dose optimization of subcutaneous atezolizumab concerns us due to th...
Pharmacokinetics of Sugammadex: An Open‐Label, 3‐Period, Fixed‐Sequence, 3‐Single‐Doses Study in Healthy Chinese Subjects
Pharmacokinetics of Sugammadex: An Open‐Label, 3‐Period, Fixed‐Sequence, 3‐Single‐Doses Study in Healthy Chinese Subjects
Abstract The main purpose of this study was to assess pharmacokinetic parameters (area under the plasma concentration ...
Pharmacokinetics, Safety, and Pharmacodynamics of Romiplostim in Chinese Subjects With Immune Thrombocytopenia: A Phase I/II Trial
Pharmacokinetics, Safety, and Pharmacodynamics of Romiplostim in Chinese Subjects With Immune Thrombocytopenia: A Phase I/II Trial
Abstract Romiplostim is approved for the treatment of immune thrombocytopenia (ITP). This study aimed to evaluate the phar...
Pharmacokinetics of Ginsenoside Compound K From a Compound K Fermentation Product, CK‐30, and From Red Ginseng Extract in Healthy Korean Subjects
Pharmacokinetics of Ginsenoside Compound K From a Compound K Fermentation Product, CK‐30, and From Red Ginseng Extract in Healthy Korean Subjects
Abstract Natural protopanaxadiol ginsenosides exhibit low absorption in the human intestine. However, ginsenoside compound...
Edoxaban Exposure in Patients With Atrial Fibrillation and Estimated Creatinine Clearance Exceeding 100 mL/min
Edoxaban Exposure in Patients With Atrial Fibrillation and Estimated Creatinine Clearance Exceeding 100 mL/min
Abstract Edoxaban 60 mg is approved for stroke prevention in patients with atrial fibrillation (AF) not fulfilling an...
Single‐ and Multiple‐Dose Pharmacokinetics and Pharmacodynamics of PN‐943, a Gastrointestinal‐Restricted Oral Peptide Antagonist of α4β7, in Healthy Volunteers
Single‐ and Multiple‐Dose Pharmacokinetics and Pharmacodynamics of PN‐943, a Gastrointestinal‐Restricted Oral Peptide Antagonist of α4β7, in Healthy Volunteers
Abstract PN-943 is an orally stable, gastrointestinal-restricted peptide that binds specifically to α4ß7 integr...
Impact of Paroxetine, a Strong CYP2D6 Inhibitor, on SPN‐812 (Viloxazine Extended‐Release) Pharmacokinetics in Healthy Adults
Impact of Paroxetine, a Strong CYP2D6 Inhibitor, on SPN‐812 (Viloxazine Extended‐Release) Pharmacokinetics in Healthy Adults
Abstract SPN-812 (viloxazine extended-release) is a novel nonstimulant recently approved as a treatment for attention-defi...
Safety, Pharmacokinetics, and Pharmacodynamics of the ADAMTS‐5 Inhibitor GLPG1972/S201086 in Healthy Volunteers and Participants With Osteoarthritis of the Knee or Hip
Safety, Pharmacokinetics, and Pharmacodynamics of the ADAMTS‐5 Inhibitor GLPG1972/S201086 in Healthy Volunteers and Participants With Osteoarthritis of the Knee or Hip
Abstract GLPG1972/S201086 is a disintegrin and metalloproteinase with thrombospondin motif-5 (ADAMTS-5) inhibitor in devel...
Surveys/Research Exploring Japanese Phase I Studies in Global Drug Development: Are They Necessary Prior to Joining Global Clinical Trials?
Surveys/Research Exploring Japanese Phase I Studies in Global Drug Development: Are They Necessary Prior to Joining Global Clinical Trials?
The pharmacokinetic (PK) and the pharmacodynamic (PD) properties of a drug and correlations of PK and PD with clinical eff...
Evaluation of Proton Pump Inhibitor Esomeprazole on Crizotinib Pharmacokinetics in Healthy Participants
Evaluation of Proton Pump Inhibitor Esomeprazole on Crizotinib Pharmacokinetics in Healthy Participants
Abstract Crizotinib is a small-molecule, multitargeted tyrosine kinase inhibitor that exhibits decreased aqueous solubilit...
Pilocarpine‐Induced Effects on Salivary Secretion as a Pharmacological Biomarker for Cholinergic Parasympathetic Activation
Pilocarpine‐Induced Effects on Salivary Secretion as a Pharmacological Biomarker for Cholinergic Parasympathetic Activation
Abstract Pilocarpine-induced salivary secretion could serve as a nontherapeutic target engagement biomarker in a clinical ...
Assessment of Pharmacokinetic Interaction Between Gefapixant (MK‐7264), a P2X3 Receptor Antagonist, and the OATP1B1 Drug Transporter Substrate Pitavastatin
Assessment of Pharmacokinetic Interaction Between Gefapixant (MK‐7264), a P2X3 Receptor Antagonist, and the OATP1B1 Drug Transporter Substrate Pitavastatin
Abstract Gefapixant (MK-7264, AF-219), a first-in-class P2X3 antagonist, is being developed as oral treatment for refracto...
The Effect of Oral Letermovir Administration on the Pharmacokinetics of a Single Oral Dose of P‐Glycoprotein Substrate Digoxin in Healthy Volunteers
The Effect of Oral Letermovir Administration on the Pharmacokinetics of a Single Oral Dose of P‐Glycoprotein Substrate Digoxin in Healthy Volunteers
Abstract Letermovir is a human cytomegalovirus (CMV) terminase inhibitor approved in the United States, Canada, Japan, and...
Evaluation of the Pharmacokinetic Interaction and Safety of Ubrogepant Coadministered With Esomeprazole Magnesium
Evaluation of the Pharmacokinetic Interaction and Safety of Ubrogepant Coadministered With Esomeprazole Magnesium
Abstract Ubrogepant is a calcitonin gene–related peptide receptor antagonist for the acute treatment of migraine. E...
A Randomized Phase 1 Evaluation of Deupirfenidone, a Novel Deuterium‐Containing Drug Candidate for Interstitial Lung Disease and Other Inflammatory and Fibrotic Diseases
A Randomized Phase 1 Evaluation of Deupirfenidone, a Novel Deuterium‐Containing Drug Candidate for Interstitial Lung Disease and Other Inflammatory and Fibrotic Diseases
Abstract LYT-100 (deupirfenidone) is a selectively deuterated form of pirfenidone under development for the treatment of i...
Phase 1 Maximal Use Pharmacokinetic Study of Tirbanibulin Ointment 1% in Subjects With Actinic Keratosis
Phase 1 Maximal Use Pharmacokinetic Study of Tirbanibulin Ointment 1% in Subjects With Actinic Keratosis
Abstract Tirbanibulin is a novel tubulin polymerization and Src kinase signaling inhibitor. This study was designed to ful...
Pharmacokinetics and Bioequivalence of a Generic and a Branded Budesonide Nasal Spray in Healthy Chinese Subjects
Pharmacokinetics and Bioequivalence of a Generic and a Branded Budesonide Nasal Spray in Healthy Chinese Subjects
Abstract The aim of this study was to evaluate the pharmacokinetic bioequivalence of a generic budesonide nasal spray and ...
Bioequivalence and Pharmacokinetic Evaluation of 2 Pyrazinamide Formulations in Healthy Chinese Adults: A Single‐Dose, Open‐Label, Randomized‐Sequence, 2×2 Crossover Study
Bioequivalence and Pharmacokinetic Evaluation of 2 Pyrazinamide Formulations in Healthy Chinese Adults: A Single‐Dose, Open‐Label, Randomized‐Sequence, 2×2 Crossover Study
Abstract A single-dose, open-label, randomized-sequence, 2×2 crossover study was conducted in healthy Chinese adults,...
A Phase 1 Open‐Label, Fixed‐Sequence Pharmacokinetic Drug Interaction Trial to Investigate the Effect of Cannabidiol on the CYP1A2 Probe Caffeine in Healthy Subjects
A Phase 1 Open‐Label, Fixed‐Sequence Pharmacokinetic Drug Interaction Trial to Investigate the Effect of Cannabidiol on the CYP1A2 Probe Caffeine in Healthy Subjects
Abstract This pharmacokinetic (PK) drug-interaction trial investigated the effects of repeated dosing of a plant-derived p...
Should Estimated Glomerular Filtration Rate Be Adjusted for Race?
Should Estimated Glomerular Filtration Rate Be Adjusted for Race?
Glomerular filtration rate (GFR) is considered the best overall measurement of kidney function and is an important clinica...
Pharmacokinetics of Opicapone and Its Metabolites in Healthy White and Chinese Subjects
Pharmacokinetics of Opicapone and Its Metabolites in Healthy White and Chinese Subjects
Abstract Opicapone (OPC) is a third-generation catechol-O-methyltransferase inhibitor developed to treat Parkinson disease...
Pharmacokinetic Interaction Among Ezetimibe, Rosuvastatin, and Telmisartan
Pharmacokinetic Interaction Among Ezetimibe, Rosuvastatin, and Telmisartan
Abstract To evaluate the pharmacokinetic interactions among rosuvastatin, ezetimibe, and telmisartan, a randomized, open-l...
Pharmacokinetics and Safety of Letermovir and Midazolam Coadministration in Healthy Subjects
Pharmacokinetics and Safety of Letermovir and Midazolam Coadministration in Healthy Subjects
Abstract Letermovir is a human cytomegalovirus (CMV) terminase inhibitor for the prophylaxis of CMV infection and disease ...
Clinical Pharmacokinetics of Daprodustat: Results of an Absorption, Distribution, and Excretion Study With Intravenous Microtracer and Concomitant Oral Doses for Bioavailability Determination
Clinical Pharmacokinetics of Daprodustat: Results of an Absorption, Distribution, and Excretion Study With Intravenous Microtracer and Concomitant Oral Doses for Bioavailability Determination
Abstract Daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, is being investigated for treatment o...
Lack of a Clinically Meaningful Drug Interaction Between the HIV‐1 Antiretroviral Agents Islatravir, Dolutegravir, and Tenofovir Disoproxil Fumarate
Lack of a Clinically Meaningful Drug Interaction Between the HIV‐1 Antiretroviral Agents Islatravir, Dolutegravir, and Tenofovir Disoproxil Fumarate
Abstract Islatravir, an investigational nucleoside reverse transcriptase translocation inhibitor, is in clinical developme...
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