Pharmacokinetics and Bioequivalence of Fixed-Dose Combination of Simvastatin and Ezetimibe Tablets: A Randomized, Crossover, Open-Label Study in Healthy Volunteers.

The current study aimed to evaluate the bioequivalence of a new generic combination of simvastatin and ezetimibe with the reference formulation. An open-label, randomized, 3-period, 3-sequence, crossover study, including 60 healthy volunteers, was implemented. Participants received the test and reference formulation, each containing 20 mg of simvastatin and 10 mg of ezetimibe as a single-dose tablet, separated by a minimum of 2-week washout periods.

Apixaban Pharmacokinetics and Bioequivalence of Two Tablet Formulations: A Randomized, Open-Label, Crossover Study, Fasting Condition in Healthy Indonesian Volunteers.

The present study aimed to assess the bioequivalence of a new apixaban generic with reference formulation. Twenty-six healthy volunteers were recruited for an open-label, balanced, randomized, 2-treatment, 2-sequence, 2-period, single oral dose study. Following overnight fasting, each volunteer received 5 mg of apixaban test and reference formulations as single doses, separated by a 1-week washout period.

Pharmacokinetics and Bioequivalence of 2 Azithromycin Tablet Formulations: A Randomized, Open-Label, 2-Stage Crossover Study in Healthy Volunteers.

The current study aimed to assess the bioequivalence of a new branded azithromycin with the reference formulation. An open-label, randomized, 2-stage, crossover study design was implemented involving 77 healthy volunteers under fasting conditions. Each volunteer received a single dose of 250-mg azithromycin tablets test and reference formulations separated by a 21-day washout period.

Toxicity Evaluation of New Generic Latanost and Latacom as an Ophthalmic Formulation.

Aim And Objective: To evaluate the safety of two new generic ophthalmic formulations, Latanost (latanoprost) and Latacom (latanoprost and timolol) by utilizing the three-dimensional reconstructed human cornea-like epithelium (RhCE) tissue constructs as an model in the assessment of ocular irritation.

Materials And Methods: irritation test was conducted on Latanost (LTN) and Latacom (LTC) and their corresponding innovators, Xalatan (XLT) and Xalacom (XLC), respectively, by using RhCE. According to the OECD guidelines No.

Pharmacokinetics and Bioequivalence Study of a New Branded Generic Moxifloxacin Tablet Among Healthy Volunteers.

A newly developed branded generic of a moxifloxacin (MOX) 400-mg tablet formulation was manufactured prior to this study. A bioequivalence (BE) study was done to assess the pharmacokinetics of the formulation using a randomized, open-label, 2-period crossover, 2-sequence, and single-dose experiment. Thirty healthy male volunteers were recruited.