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Table 2 Pharmacokinetic results based on measured plasma study drug concentrations (N = 36)a

From: Relative bioavailability of diazoxide, manufactured at two different international locations, in healthy participants under fasting conditions: an open-label, two-stage, adaptive, sequential two-period crossover study

Parameter Product GM GM, 95% CI GMR (Test vs Reference), % GMR, 90% CI Pseudo Intra-participant % CVb
AUC0-t, ng.hour/mL Test 200,000 184,000–217,000 108.01 105.08-111.03 6.9
  Reference 185,000 170,000–201,000 - - -
AUC0-inf, ng.hour/mL Test 244,000 219,000–272,000 106.12 102.62–109.75 8.4
  Reference 230,000 206,000–257,000 - - -
Cmax, ng/mL Test 5,830 5,450–6,230 116.89 113.66–120.22 7.0
  Reference 4,990 4,680–5,320 - - -
  1. AUC 0-inf area under the curve from time zero to infinity, AUC 0-t area under the curve from time zero to the time of the last measurable analyte concentration, C max maximum plasma analyte concentration, CI confidence interval, CV coefficient of variation, GM geometric mean, GMR geometric mean ratio
  2. aA nonzero predose concentration level was obtained at the beginning of period 2 in one participant. However, the measured predose level was < 1% of the participant’s corresponding Cmax value. In compliance with the protocol, the predose level was maintained in the pharmacokinetic analysis without baseline correction
  3. bEstimated based on the elements of the variance-covariance matrix as: CV(%) = 100*sqrt[(σA2 + σB2 − 2*σAB)/2], where A and B are the two treatments
  4. Test, PROGLICEM® 100 mg hard capsules, Batch No.: 3107A (Merck Sharp & Dohme Corp, USA); reference, PROGLYCEM® 100 mg capsules, Lot No.: 120118 (Merck Canada Inc., Canada)