- P-ISSN 1225-0163
- E-ISSN 2288-8985
- P-ISSN1225-0163
- E-ISSN2288-8985
- SCOPUS, ESCI, KCI
Article Detail
Home > Article Detail
Bioequivalence of pioglitazone tablet to Actos® tablet(Pioglitazone 30 mg)
Analytical Science and Technology / Analytical Science and Technology, (P)1225-0163; (E)2288-8985
2009, v.22 no.1, pp.101-108
&
(2009). Bioequivalence of pioglitazone tablet to Actos® tablet(Pioglitazone 30 mg). , 22(1), 101-108.
Abstract
The bioequivalence of two pioglitazone tablets, Actos® tablet (Takeda Chemical Industries, reference drug) and Pioglitazone tablet (Boryung Company, test drug) was evaluated according to the guidelines of Korea Food and Drug Administration. Twenty-eight healthy male Korean volunteers received each medicine (pioglitazone dose of 30 mg) in a 2×2 crossover study with one week washout interval. After drug administration, blood samples were collected at specific time intervals from 0-36 hours. The plasma concentrations of pioglitazone were determined by high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS). The total chromatographic run time was 5 min and calibration curves were linear over the concentration range of 5-2000 ng/mL for pioglitazone. The method was validated for selectivity, sensitivity, linearity, accuracy and precision. The pharmacokinetic parameters were determined from the plasma concentration-time profiles of both formulations. The primary calculated pharmacokinetic parameters were compared statistically to evaluate bioequivalence between the two preparations. The 90% confidence intervals of the AUCt ratio and the Cmax ratio for Pioglitazone tablet and Actos® tablet were log0.9422~log1.1040 and log0.9200~log1.1556, respectively. Based on the statistical considerations, we can conclude that the test drug, Pioglitazone tablet was bioequivalent to the reference drug, Actos® tablet.
- keywords
- pioglitazone, bioequivalence, LC-MS/MS, analytical validation
Other articles from this issue
- Process analytical technology (PAT): field applications and current status in pharmaceutical industries
- Analysis of mercury and methylmercury in river sediment samples
- Age comparisons of coastal sand dune stratum in Chollipo, Korea by altering preheat and cut-heat, and grain size distributions by OSL dating
- Development of a building materials database; Volatile organic compounds, formaldehyde emission rates and chemical compositions
- The analysis of the urushiol congeners from the extracts of lacquer trees
- Study on the size-based separation of nano to micron particles in natural water and soil using flow and sedimentation Field-flow fractionation
- Preparation and evalution of limestone reference material for a proficiency test
- Adsorption of uranium(Ⅵ), calcium(Ⅱ), and samarium(Ⅲ) ions on synthetic resin adsorbent with styrene hazardous materials
- Bioequivalence of pioglitazone tablet to Actos® tablet(Pioglitazone 30 mg)
- Analysis of polycyclic aromatic hydrocarbons in cooked fish and shellfish
- more
Recommanded Articles
This website recommended the use the Chrome browser for journal website.