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Inter-laboratory CV was comparable for both products (Table 2).
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The mean concentration-time profile is shown in Figure 1 and the mean pharmacokinetic parameters are shown in Table 4. Pharmacokinetic parameters of Tmax, Cmax and AUC show Impede™ tablets (test) to be similar to control (reference), reflecting that therapeutic levels of pseudoephedrine would be comparable for the two products.
Treatment procedures for both products were identical.
OH emission was comparable for both fuel injection conditions.
The selectivity against nitrogen was comparable for both membranes.
The equilibrium time was low and comparable for both adsorbents.
However, liver uptake was significant and comparable for both tracers at all time points.
Incidence and severity of hyperkalaemia (>5.0 mmol/l) were comparable for both protocols.
The incidence/type of AEs was comparable for both groups.
Apparently the variation in prescription is comparable for both groups.
The dropout rates were also comparable for both regimens.
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