Articles Related to pharmacokinetic
Bioequivalence Studies of Two Formulations of Rivaroxaban 10 Mg Coated Tablets under Fasting Conditions and 20 Mg Coated Tablets Under Fed and Fast Conditions And its Pharmacokinetic Comparison In Healthy Subjects
Justificative: This trial was conducted in order to register a new generic product of Rivaroxaban.
Objective: To evaluate the bioequivalence of rivaroxaban formulations manufactured by Eurofarma Laboratórios S/A and
the reference drug, Xarelto (Bayer) under fasting and fed conditions.
Methods: Three randomized, open label, balanced, 2 treatments, 4 periods, 2 sequences, single dose, full replicate, crossover
studies in 48 healthy adult human subjects under fed and fasting conditions for rivaroxaban 10 mg and 20 mg. Rivaroxaban
concentrations in plasma were determined using a validated HPLC-MS/MS method.
A Bioequivalence Study of Two Formulations of Lacosamide
This study was conducted to compare the bioavailability of two tablet formulations containing 200 mg Lacosamide (one Lacosamide 200 mg film-coated tablet marketed in Italy as Ollat®, one Vimpat® coated tablet). 20 healthy subjects were enrolled in a single-center, randomized, single-dose, laboratory-blinded, 2-period, 2-sequence, crossover study, with a minimum washout period of 7 days. All the 20 subjects completed the study. Plasma samples were collected up to 72.0 hours post-dosing. Lacosamide levels were determined using a validated high-performance liquid chromatography
with tandem mass spectrometry (HPLC/MS/MS) method
Randomised, 2-Sequence, 4-Period Replicate Cross-Over Bioequivalence Study of A New Riluzole Orodispersible Film Vs. A Reference Tablet in Healthy Volunteers
Purpose: The present bioequivalence study aimed at demonstrating the bioequivalence of a recently developed novel riluzole orodispersible film vs. a reference tablet.
Methods: Healthy male and female volunteers received single oral doses of 50 mg of riluzole, as test and reference formulation, under fasting conditions, in each of 4 subsequent periods separated by wash-out intervals of at least 7 days, according to a 2-treatment, 4-period, replicate randomised cross-over design.
Findings: Riluzole plasma concentrations were almost superimposable. Riluzole attained a similar peak concentration (315.62±124.95 ng/mL with the film and 278.81±123.32 ng/mL with the tablet) at a median tmax of 0.75 h after both treatments. Then, riluzole plasma concentrations showed a superimposable decline from the peak up to 36 h post-dose, with mean half-lives of 10.22±1.66 and 10.22±1.48 h with the film and the tablet. Mean AUC0-t was 1263.40±571.58 h*ng/mL with the film and 1135.98±514.98 h*ng/mL with the tablet. The 90% confidence intervals of Cmax, AUC0-t and AUC0-¥ of riluzole fell within the predefined range 80.00-125.00%. The treatments did not differ significantly either in tmax or t1/2. On average, the test orodispersible film dissolved on the tongue in a median time of about 2.5 min with a range of 0.7-5.7 min. Orodispersible film palatability was good or acceptable for most subjects.
Bioequivalence Study of Donepezil 10 mg Orally Disintegrating Tablets in Healthy Thai Volunteers Under Fasting Conditions
Donepezil is a potent, selective, noncompetitive and reversible inhibitor of acetylcholinesterase, commonly used for the treatment of Alzheimer’s disease. The form of orally disintegrating tablets (ODTs) is a good alternative dosage form for patients who have a difficulty in swallowing conventional tablets or capsules.
Comparative Bioequivalence Studies of Pantoprazole 40 mg Delayed-Release Tablet Formulations in Healthy Thai Volunteers
Pantoprazole is a H+,K+-ATPase enzyme inhibitor for the treatment of acid-related gastrointestinal diseases. The Government Pharmaceutical Organization (GPO), Thailand had developed Pantoprazole GPO® (pantoprazole 40 mg delayed-release tablets) as a generic substitute for the corresponding innovator product, CONTROLOC® 40 mg.
Bioequivalence of Two Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate 600/200/300 mg Fixed-Dose Combination Tablets in Healthy Thai Male Volunteers under Fasting Conditions
Fixed-dose combination tablet formulation of efavirenz/emtricitabine/tenofovir disoproxil fumarate 600/200/300 mg is an antiretroviral
therapy comprising one non-nucleoside reverse-transcriptase inhibitor and two nucleoside reverse-transcriptase inhibitors to control
human immunodeficiency virus infection.
Pharmacokinetics Bridging Study of a 400 Mg Extended Release Formulation of the Novel Fumaric Acid Ester PPC-06 (Tepilamide Fumarate) in Healthy Male Volunteers
Tepilamide fumarate (PPC-06) is a new, patented prodrug of monomethyl fumarate (MMF), belonging to the fumaric acid esters
(FAEs) class of drugs. The efficacy and safety of a 400 mg PPC-06 dose administered twice daily, achieved thus far through concomitant
intake of two tablets of 200 mg, was demonstrated previously in two Phase 2 clinical trials on patients with moderate to severe chronic
plaque-type psoriasis.
Bioequivalence Evaluation of Two Clopidogrel Immediate Release Tablet Formulations in Healthy Thai Volunteers Under Fasting Conditions
Clopidogrel is used for acute coronary syndrome and prevention of atherothrombotic events. To improve clinical outcomes, patient
adherence to treatment is necessary. However, continuous use of branded product may cause economic burden to patients and
healthcare system. The Government Pharmaceutical Organization (GPO), Thailand had developed a generic product of clopidogrel to
reduce cost of treatment and improve accessibility to medicines for Thai people.
Bioequivalence between Two Tablets of Levetiracetam in Healthy Subjects under Fasting Condition
Bioavailability of two formulations containing levetiracetam 750 mg film-coated tablets was compared in a fasting bioequivalence study. The study was single dose, randomized, open label, and two-period crossover, with Brazilian healthy subjects, males and nonpregnant females. Blood samples were taken for 36 hours after drug administration and plasmatic concentrations were determined using a validated HPLC-MS/MS method. Confidence intervals (CI90%) for the peak plasma concentration (Cmax) and area under the
concentration-time curve (AUC0-t) were determined by calculating LN-transformed data. The ratios and 90% CI for the geometric mean test/reference were 97.41% (91.45- 103.75%) for Cmax and 99.77% (97.07- 102.54%) for AUC0-t.
Bioequivalence Study of Olanzapine 5 mg Orally Disintegrating Tablet Formulations in Healthy Thai Volunteers under Fasting Conditions
A comparative randomized, single dose, two-way crossover, open label study was carried out to assess bioequivalence and tolerability of test (ZOLAN GPO®) and reference (Zyprexa Zydis®) products of olanzapine 5 mg orally disintegrating tablets for interchange ability in the same quality and safety.
A Bioequivalence Study of Two Formulations of Rosuvastatin
Aim of this study was to compare the bioavailability of two tablet formulations containing Rosuvastatin: Rosuvastatin tablets 40 mg manufactured by MacLeods Pharmaceuticals Ltd. (marketed in Italy with the brand name Exorta®) and CRESTOR® 40 mg tablets marketed by Astra Zeneca.
A Bioequivalence Study of Two Formulations of Levetiracetam
This study was conducted to compare the bioavailability of 1000 mg levetiracetam film-coated tablet, marketed in Italy as Italept®, with Keppra® coated tablet.
Dose-Dependent Pharmacokinetics of Ropivacaine in Anesthetized Rabbits: Absence of Changes in Protein Binding
The primary objectives of this study were to investigate the in vivo pharmacokinetics and in vitro plasma protein binding of
ropivacaine at the concentration range observed after intravenous administration of different doses in anesthetized rabbits.
Pharmacokinetics of a 1,000 mg Disintegrating Aspirin Tablet Formulation
Migraine is a global disorder and considerably affecting people`s quality of life. Treatments include nonsteroidal anti-inflammatory drugs-containing medicinal products among whom acetylsalicylic acid-containing Aspirin® has been proven effectively to relief migraine headache. Early treatment is recommended for patients with migraine attacks.
Evaluating the Effect of Oprelvekin on Cardiac Repolarization in Subjects with Chemotherapy-Induced Thrombocytopenia: An Observational Chart Review of a Phase 2 Clinical Trial in Laredo, Texas
This study tested for the cardiac effects of Oprelvekin, recombinant human interleukin-11, a thrombopoietic growth factor, in patients afflicted with chemotherapy-induced thrombocytopenia (platelet count<50,000 cells/ul). Chart-reviews of patients fulfilling the inclusion criteria of: 18-75 yrs of age, non-myeloid malignancy, with adequate hematologic, hepatic and renal parameters and normal electrocardiograms that were enrolled in this phase 2 trial were analyzed. Patients of child-bearing potential agreed to be on a reliable form of birth control for the duration of the study. Results on 4 patients suggest that Oprelvekin does not cause atrial nor ventricular arrhythmia, a rare severe cardiac side effect, in treating patients with chemotherapy-induced thrombocytopenia.
Editorial Board Members Related to pharmacokinetic
ALAA EL-DEEN BAKRY YASSIN
Associate Professor
Department of Pharmaceutical Sciences
King Saud bin Abdulaziz University for Health Sciences
Saudi Arabia
Department of Pharmaceutical Sciences
King Saud bin Abdulaziz University for Health Sciences
Saudi Arabia
MD Ibrahim El Said Ali El-Gamal
Assistant Professor
College of Pharmacy
Department of Medicinal Chemistry
University of Sharjah
UAE
College of Pharmacy
Department of Medicinal Chemistry
University of Sharjah
UAE
Yanyan Li
Assistant Professor
Department of Health and Nutrition Sciences
Montclair State University
United States
Department of Health and Nutrition Sciences
Montclair State University
United States
Ahmed S. Zidan
Associate Professor
Department of Pharmaceutics and industrial pharmacy
Zagazig University
Egypt
Department of Pharmaceutics and industrial pharmacy
Zagazig University
Egypt
Kit-Lam Chan
Professor
School of Pharmaceutical Sciences
Universiti Sains Malaysia
Malaysia
School of Pharmaceutical Sciences
Universiti Sains Malaysia
Malaysia
Marc G. Sturgill
Associate Professor and Chair
Department of Pharmacy Practice & Administration
Ernest Mario School of Pharmacy
Rutgers University
United States
Department of Pharmacy Practice & Administration
Ernest Mario School of Pharmacy
Rutgers University
United States
David Ilki Min
Professor
Pharmacy Practice and Administration
Western University of Health Sciences
United States
Pharmacy Practice and Administration
Western University of Health Sciences
United States
Nashiru Billa
Associate professor
Faculty of Science
University of Nottingham
Malaysia
Faculty of Science
University of Nottingham
Malaysia
Joseph Pergolizzi
Adjunct Assistant Professor
Department of Medicine
Johns Hopkins University
United States
Department of Medicine
Johns Hopkins University
United States