Articles Related to Bioequivalence
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
Bioequivalence Study of Two 80 Mg Valsartan Tablets Formulations in Healthy Chinese Subjects Under Fasting and Fed Condition
Objective: The purpose of this study was to compare the bioavalability between the two 80 mg Valsartan Tablets formulations and to evaluate the bioequivalence of Reference and Test formulations of Valsartan Tablets 80 mg in Healthy adult chinese Male and Female subjects under Fasting and Fed condition.
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.
Population Bioequivalence (PBE) Statistical Method to Evaluate Particle Size Distribution of Unilamellar Liposomes Constructed by Microfluidic Chip
Due to the high variability characteristics of liposome products and the influence of particle size on the distribution, tissue
targeting behavior and clinical efficacy of liposomes, population bioequivalence (PBE) statistical method was selected to evaluate the
consistency of particle size distribution of liposomes continuously prepared by microfluidic chip technology.
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.
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 Capsules of Pirfenidonein Healthy Subjects under Fed Condition
Pirfenidone capsules are indicated for the treatment of patients with Idiopathic pulmonary fibrosis. The Bioavailability of two
formulations containing pirfenidone 267 mg hard gelatin capsules was compared in a bioequivalence study under fed conditions. The
study was single dose, randomized, open label, two-period crossover, with Brazilian healthy subjects, males and nonpregnant females.
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.
Determination of N-Butylscopolamine in Human Plasma by Solid-Phase Extraction and UHPLC-ESI-MS/MS: Development, Validation and Application to a Bioequivalence Study
BioequivalenceA sensitive ultra performance liquid chromatography-electrospray ionization-tandem mass spectrometry (UHPLC-ESI-MS/MS) method for measurements of N-butylscopolamine in plasma was developed and validated. A SPE extraction was proposed for the clean up of plasma and N-butylscopolamine-d9 was added as internal standard. The analyses were carried out using a phenyl column and mobile phase of acetonitrile:
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.
Editorial Board Members Related to Bioequivalence
Eyad Mazin Mallah
Associate professor
Department of Pharmaceutical Medicinal Chemistry and Pharmacognosy
University of Petra
Jordan
Department of Pharmaceutical Medicinal Chemistry and Pharmacognosy
University of Petra
Jordan
