Articles Related to Bioequivalence Study
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.
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.
Bioequivalence Study of Two Oral-Capsule Formulations of Omeprazole 20 mg in Combination with Sodium Bicarbonate in Healthy Mexican Adult Volunteers
In Mexico, the immediate-release formulation of omeprazole 20 mg in combination with 1100 mg of sodium bicarbonate (oral capsules) is indicated for patients over 18 years for the treatment of gastritis, reflux, heartburn and the sensation of emptiness caused by the excessive acid production.
Bioequivalence Study of Two Oral-Capsule Formulations of Pregabalin 300 mg in Healthy Mexican Adult Volunteers
Pregabalin is a ligand for the alpha-2-delta subunit of voltage-gated calcium channels in the central nervous system. It has anticonvulsant, analgesic, and anxiolytic activity. The bioequivalence of a test formulation was evaluated with respect to its corresponding reference drug formulation of oral pregabalin 300 mg, administered as a capsule. This randomized-sequence, single-dose, single-blind, two-period crossover design under fasting conditions was done on 25 healthy Mexican adult subjects including both genders. There was a seven-day washout period.
Relative Bioavailability of Ciprofloxacin Doses (750 and 1000) mg in Healthy Male Volunteers by Using HPLC Method
A new, stable and accurate high performance liquid chromatography ultraviolet spectrophotometric method for quantitation of Ciprofloxacin in human plasma was developed and validated.