Oruvail capsules - Administration of Oruvail with a high-fat meal causes a delay of about 2 hours in reaching the C_max; neither the total bioavailability (AUC) nor the C_max is affected. Circadian changes in the absorption process have not been studied.

The administration of antacids or other drugs which may raise stomach pH would not be expected to change the rate or extent of absorption of ketoprofen from Oruvail capsules.

Steady-state concentrations of ketoprofen are attained within 24 hours after commencing treatment with Orudis or Oruvail capsules. In studies with healthy male volunteers, trough levels at 24 hours following administration of Oruvail 200 mg capsules were 0.4 mg/L compared with 0.07 mg/L at 24 hours following administration of Orudis 50 mg capsules QID (12 hours), or 0.13 mg/L following administration of Orudis 75 mg capsules TID for 12 hours. Thus, relative to the peak plasma concentration, the accumulation of ketoprofen after multiple doses of Oruvail or Orudis capsules is minimal.

The figure below shows a reduction in peak height and area after the second 50 mg dose. This is probably due to a combination of food effects, circadian effects, and plasma sampling times. It is unclear to what extent each factor contributes to the loss of peak height and area.

The shaded area represents ±1 standard deviation (S.D.) around the mean for Orudis or Oruvail.

KETOPROFEN PLASMA CONCENTRATIONS IN SUBJECTS RECEIVING 200 MG OF ORUVAIL ONCE A DAY (QD), OR ORUDIS 50 MG EVERY 4 HOURS FOR 16 HOURS

COMPARISON OF PHARMACOKINETIC PARAMETERS^# FOR ORUDIS AND ORUVAIL

# Values expressed are mean ± standard deviation
¹ In the case of Oruvail, absorption is slowed, intrinsic clearance is unchanged, but because the rate of elimination is dependent on absorption, the half-life is prolonged.

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