Article

Evaluation of Bioequivalence of Two Formulations Containing 100 Milligrams of Aceclofenac

Department of Pharmaceutical Technology, Jadavpur University, Kolkata, India.
Drug Development and Industrial Pharmacy (Impact Factor: 2.1). 12/2006; 32(10):1219-25. DOI: 10.1080/03639040600608805
Source: PubMed

ABSTRACT

The bioequivalence of two oral formulations containing aceclofenac 100 mg was determined in 24 healthy Indian male volunteers. The study was designed as a single dose, fasting, two-period two-sequence crossover study with a washout period of 1 week. The content of aceclofenac in plasma was determined by a validated HPLC method with UV detection. The preparations were compared using the parameters area under the plasma concentration-time curve (AUC0-t), area under the plasma concentration-time curve from zero to infinity (AUC0-infinity), peak plasma concentration (Cmax), and time to reach peak plasma concentration (tmax). No statistically significant difference was observed between the logarithmic transformed AUC0-infinity and Cmax values of the two preparations. The 90% confidence interval for the ratio of the logarithmic transformed AUC0-t, AUC0-infinity, and Cmax were within the bioequivalence limit of 0.80-1.25.

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Available from: Uttam Kumar Mandal, Sep 19, 2014
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    • "The relationship between the concentration and peak area was found within the range 0.1–5 µg/ml during linearity studies. Quality control points at low, medium, and high levels were used to determine absolute recovery and within-day (intraday) and between-day (interday) precision and accuracy [7]. "
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