Clinical Evaluation of an Investigational 5 mL Wearable Injector in Healthy Human Subjects.

An investigational wearable injector (WI), the BD Libertas Wearable Injector (BD Libertas is a trademark of Becton, Dickinson and Company), was evaluated in an early feasibility clinical study for functional performance, tissue effects, subject tolerability, and acceptability of 5 mL, non-Newtonian ~ 8 cP subcutaneous placebo injections in 52 healthy adult subjects of 2 age groups (18-64 years and ≥ 65 years). Randomized WI subcutaneous injections (n = 208, 4/subject) were delivered to the right and left abdomen and thigh of each subject, 50% (1 thigh and 1 abdomen) with a defined movement sequence during injection. Injector functional performance was documented.

Bioequivalence studies of tacrolimus capsule under fasting and fed conditions in healthy male and female subjects.

The bioequivalence of tacrolimus (CAS 104987-11-3) 5 mg capsules was assessed in two single-dose, open-label, randomIzed 2-way crossover trials with a minimum washout period of 14 days; one trial was conducted under fasting condition (n = 44) and the other one under fed condition (n = 48). Blood samples were collected over a 120-h period and concentrations were assayed using a liquid chromatography tandem mass spectrometry (LCMS/MS) method. A non-compartmental method was used for calculation of pharmacokinetic parameters.

In vitro disintegration and dissolution and in vivo bioequivalence of two alendronate once-weekly formulations.

Bioequivalence of two tablet formulations of 70 mg alendronate (CAS 121268-17-5) was assessed in a single-dose, open-label, randomised, fasted state crossover trial, with a washout period of 21 days, in 80 healthy subjects. Urine samples were collected up to +36 h post dosing and the concentrations of alendronic acid were assessed using a high-performance liquid chromatographic method with pre-derivatization and fluorescence detection (HPLC/FL) method. The 90 % confidence intervals (90 % CI) obtained for Ae0-36 (cumulative urinary excretion) and Rmax (maximum rate of urinary excretion) were 98.

Comparative bioavailability of two formulations of terbinafine. Data from a cross-over, randomised, open-label bioequivalence study in healthy volunteers.

An open-label, randomised, cross-over single dose study, using 2 periods x 2 sequences, with a minimum washout period of 21 days, was conducted in order to assess the comparative bioavailability of two formulations of terbinafine (CAS 78628-80-5) 250 mg tablets. Plasma samples were obtained at baseline, +0.333; 0.

In vivo bioequivalence of oral antidiabetic agents: pioglitazone tablets.

The study was designed to evaluate the bioequivalence of two pioglitazone (CAS 112529-15-4) formulations. The trial was performed in 26 healthy male volunteers with the aim of comparing a new generic product (tablets containing 30 mg pioglit-azone hydrochloride, test) with the originator product (reference). The trial was performed according to an open, crossover design in one study centre.

Bioequivalence study of clopidogrel bisulfate film-coated tablets.

The aim of the present study was to evaluate the bioequivalence of two clopidogrel (CAS 120202-66-6) formulations. The study was performed according to an open, cross-over design in one study center in 36 healthy male and female volunteers, comparing a new generic product (tablets containing clopidogrel bisulfate, 75 mg) with the originator product (reference). In each of the two study periods (separated by a wash-out of 7 days) a single dose of 150 mg (test or reference) was administered.

Bioequivalence studies on bisphosphonates: the example of alendronate.

The study was designed to evaluate the bioequivalence of two formulations of alendronate (CAS 121268-17-5, Osalen 10 mg tablets, in the following referred to as "test" vs. the originator product, in the following referred to as "reference") in 89 healthy male and female volunteers, who were administered four 10 mg alendronate tablets under fasting conditions. The trial was performed according to an open, randomized, cross-over design with a wash-out period of 14 days in one study center.