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HERDIN Record #: PCHRDPC971656 Submitted: 16 May 2007 Modified: 27 February 2018

A blocked randomized cross-over controlled trial comparing the biovailability of single oral dose INH and INH+B6 in healthy Filipino volunteers.

 San Gabriel-Gonzalez,
 Garayblas MGM,
 Paje-Villar EB,
 Tan-Torres TE

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A simple cross-over bioavailability study on 12 normal male Filipino adults, with mean age of 23.16+-3.73 years, mean height of 164.5+-10.6 cms. and mean weight of 55.33+-5.36 kgs. comparing a single oral dose of INH + vitamin B6 (test drug B) as conducted using a specific High Pressure Liquid Chromatography (HPLC). Results indicate that Drug a is bioequivalent to Drug B with respect to areas under the curve (AUC O- 10 hrs) based on the 95% confidence interval criteria using the Classifical and Westlake methods. Furthermore, there is no evidence to conclude on the basis of statistical differences that Drug A and Drug B are not bioequivalent in Tmax and Cmax and AUC (0-10 hrs).(Author)

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