A bioequivalence study of two tamsulosin sustained-release tablets in Indonesian healthy volunteers.
Summary of "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. A one-week wash-out period was applied. Blood samples were drawn up to 72 h following drug administration. Plasma concentration of tamsulosin was determined by liquid chromatography-tandem mass spectrometry method with TurboIonSpray mode. Pharmacokinetic parameters AUC(0-t,) AUC(0-∞), C (max) and t (½) were determined and used for bioequivalence evaluation after log-transformation, whereas t (max) ratios were evaluated non-parametrically. The estimated point and 90% confidence intervals (CI) for AUC(0-t,) AUC(0-∞), C (max) and t (½) were 109.55% (96.41-124.49%), 109.94% (96.85-124.81%), 105.87% (92.88-120.67%) and 100.00% (90.56-110.43%), respectively. These results indicated that the two formulations of tamsulosin were bioequivalent; therefore they may be prescribed interchangeably.
Affiliation
Clinisindo Laboratories, Jakarta, Indonesia, budi.prasaja@clinisindo.com.
Journal Details
This article was published in the following journal.
Name: European journal of drug metabolism and pharmacokinetics
ISSN: 0378-7966
Pages:
Links
- PubMed Source: http://www.ncbi.nlm.nih.gov/pubmed/21432621
- DOI: http://dx.doi.org/10.1007/s13318-011-0033-1
Medical and Biotech [MESH] Definitions
Tablets, Enteric-coated
Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)
Drug Implants
Small containers or pellets of a solid drug implanted in the body to achieve sustained release of the drug.
Domperidone
A specific blocker of dopamine receptors. It speeds gastrointestinal peristalsis, causes prolactin release, and is used as antiemetic and tool in the study of dopaminergic mechanisms.
Inappropriate Adh Syndrome
A condition of HYPONATREMIA and renal salt loss attributed to overexpansion of BODY FLUIDS resulting from sustained release of ANTIDIURETIC HORMONES which stimulates renal resorption of water. It is characterized by normal KIDNEY function, high urine OSMOLALITY, low serum osmolality, and neurological dysfunction. Etiologies include ADH-producing neoplasms, injuries or diseases involving the HYPOTHALAMUS, the PITUITARY GLAND, and the LUNG. This syndrome can also be drug-induced.
Lactose
A disaccharide of GLUCOSE and GALACTOSE in human and cow milk. It is used in pharmacy for tablets, in medicine as a nutrient, and in industry.
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