Rectal Administration of Ibuprofen: Comparison of Enema and Suppository Form.

Ibuprofen is a widely used and well-tolerated analgesic and antipyretic. It is desirable to have a formulation with a rapid rate of absorption because it is required for rapid pain relief and temperature reduction. Previous studies have described the pharmacokinetic profiles of ibuprofen suppository and the mean peak times of ibuprofen suppository were around 1.

A bioequivalence study of two telmisartan 80 mg tablets in healthy Indonesian subjects: an open label, three-way, three-period, partial replicate crossover study.

Telmisartan is highly variable drug indicated for treatment of hypertension. This study aimed to compare the bioavailability of two 80 mg telmisartan tablets in healthy Indonesian subjects. A randomized, open-label, single-dose, three-sequence, three-way, reference-formulation-replicated crossover study was conducted under fasting period with two-week washout period.

Efficacy and tolerability of a nutraceutical combination of red yeast rice, guggulipid, and chromium picolinate evaluated in a randomized, placebo-controlled, double-blind study.

Hypercholesterolemia is the major risk factor in the development of coronary heart disease. Coronary heart disease is a leading cause of morbidity and mortality in many countries worldwide. An increasing attention is now paid to nutraceuticals development for prevention and cure of dyslipidemia, especially for patients who do not wish to use chemical statins.

Bioequivalence of two memantine tablet formulations in healthy Indonesian subjects.

Aim: To compare the bioequivalence of two 10-mg memantine tablet formulations.

Materials And Methods: 19 subjects were included in this single-dose, open-label, randomized, two-way crossover study following an overnight fast. A 5-week washout period was applied.

Study on bioequivalence of beraprost in healthy volunteers by liquid chromatography with tandem mass spectrometry.

Beraprost sodium is an oral prostacyclin analog that was first approved in 1992 (Japan) for the treatment of peripheral vascular disorders. It is administered orally as a tablet available in strength 20 μg. In this paper, we described a liquid chromatography tandem mass spectrometry method that was developed for the quantification of beraprost in human plasma with high sensitivity at picogram per milliliter concentration.

In-vitro Equilibrium Phosphate Binding Study of Sevelamer Carbonate by UV-Vis Spectrophotometry.

Sevelamer carbonate is a cross-linked polymeric amine; it is the active ingredient in Renvela tablets. US FDA provides recommendation for demonstrating bioequivalence for the development of a generic product of sevelamer carbonte using in-vitro equilibrium binding study. A simple UV-vis spectrophotometry method was developed and validated for quantification of free phosphate to determine the binding parameter constant of sevelamer.

A bioequivalence study of quetiapine 25 mg film-coated tablets in healthy Indonesian subjects .

Aim: This study was conducted in order to compare the bioavailability of two film-coated tablets containing 25 mg of quetiapine.

Methods: 24 subjects were enrolled in and completed a single-center, randomized, single-dose, open-label, two-way crossover study with a 1-week washout period. Plasma samples were collected up to 24 hours following drug administration; thus, quetiapine was determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS) method with turbo-ion-spray mode.

Impact of Truncated Area on Point Estimate and Intra-Subject Variability in Bioequivalence of Dutasteride with Long Half-Life.

Purpose: To investigate the effect of using truncated area under the curve (AUC) on bioequivalence of dutasteride with long half-life in point estimate and intra-subject variability.

Methods: Fifteen subjects were enrolled in this single-dose, open-label, randomized two-way crossover design following an overnight fasting with five-week washout period. Plasma samples were collected to 72 h and 144 h following drug administration and dutasteride were determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods.

Bioequivalence study of two rosuvastatin tablet formulations in healthy Indonesian subjects.

Aim: To compare the bioavailability of two 40-mg Rosuvastatin tablet formulations.

Methods: 24 subjects were included in this single-dose, open-label, randomized, two-way crossover study following an overnight fast. A 2-week wash out period was applied.

A bioequivalence study of two tamsulosin sustained-release tablets in Indonesian healthy volunteers.

The bioavailability of two 0.4 mg tamsulosin sustained-release film-coated tablet formulations was compared; using generic tablets (Prostam(®)) as test formulation and the originator product as reference formulation. Twenty-four subjects were included in this single-dose, open-label, randomized two-way crossover design following an overnight fasting.

Comparative bioavailability of two irbesartan/hydrochlorothiazide tablet formulations in Indonesian healthy subjects.

Aim: The bioavailability of two 300 mg irbesartan (CAS 138402-11-6)/12.5 mg hydrochlorothiazide (CAS 58-93-5) tablet formulations was compared, using Co-Ir-vell tablets as test formulation and the originator product as reference formulation.

Methods: Twenty-four subjects were included in this single-dose, open-label, randomized two-way crossover study following an overnight fasting.

Comparative bioavailability of two dexamethasone tablet formulations in Indonesian healthy volunteers.

Aim: To compare the bioavailability of two dexamethasone (CAS 50-02-2) tablet formulations -- 4 mg Dexmethsone tablets as test formulation and 4 mg tablets of the originator product as reference formulation.

Methods: The study was conducted according to an open-label, randomized two-way crossover design with a one-week washout period. Twenty-four volunteers received a single dose of two tablets of the two different dexamethasone formulations.

Simultaneous quantification of losartan and active metabolite in human plasma by liquid chromatography-tandem mass spectrometry using irbesartan as internal standard.

A simple and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method employing electronspray ionization was developed and validated for quantification of losartan and its carboxylic acid metabolite in human plasma using irbesartan as internal standard (IS). Following a simple pretreatment procedure, the analytes were separated using a gradient mobile phase on reverse phase C18 column. Selected reaction monitoring was specific for losartan, losartan acid and irbesartan.

Comparative bioavailability of two estazolam tablet formulations in Indonesian healthy volunteers.

Aim: To compare the bioavailability of two estazolam (CAS 29975-16-4) tablet formulations (Estalin 2 mg tablets as test formulation and 2 mg tablets of the originator product as reference formulation).

Methods: The study was conducted according to an open label, randomized two-way cross-over design with a two-week washout period. Twenty-four subjects received each of the two estazolam formulations.