Key result
A 300 mg sustained-release quinidine tablet demonstrated equivalent absorption to an oral solution, with a mean AUC of 8744.4 ng x h ml-1 versus 9145.9 ng x h ml-1.
Why the study?
Is the bioavailability of a commercial sustained-release quinidine tablet equivalent to an oral quinidine solution in normal subjects?
RCT (n=18)
cross-over
Is the bioavailability of a commercial sustained-release quinidine tablet equivalent to an oral quinidine solution in normal subjects?
Absolute Event Rate: 8744.4% vs 9145.9%
A commercial sustained-release quinidine tablet provides an equivalent extent of absorption compared to an oral solution, despite lower and later peak plasma levels.
May support sustained-release quinidine tablets for equivalent exposure; leaves open clinical efficacy and safety data in patients.
The bioavailability of quinidine sulfate after oral administration of a commercial sustained-release quinidine tablet was compared with that of oral quinidine sulfate solution in 18 normal subjects. Three hundred milligrams of each product was administered to each subject in standard cross-over fashion on separate occasions, with plasma quinidine levels measured for 46 h after each dose. Although peak plasma quinidine levels were lower, and occurred later, after tablet administration than after solution, analysis of the area under the plasma quinidine level-time curve (AUC) values for each product indicated that the products were equivalent, in terms of the extent of absorption, with the mean AUC (0-46 h) value for the tablet, 8744 . 4 ng x h ml-1, comparable to that of the solution, 9145 . 9 ng x h ml-1.
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Sawyer et al. (1982) conducted an RCT in Healthy volunteers (n=18). Sustained-release quinidine tablet vs. Oral quinidine sulfate solution was evaluated on Area under the plasma quinidine level-time curve (AUC) (0-46 h). A 300 mg sustained-release quinidine tablet demonstrated equivalent absorption to an oral solution, with a mean AUC of 8744.4 ng x h ml-1 versus 9145.9 ng x h ml-1.
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