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Table 4 Statistical comparisons of plasma pharmacodynamic parameters following a single 25-mg dose of warfarin administered alone and with 10 or 25 mg OCA–PK/PD population (N = 43)

From: Assessment of Pharmacokinetic Interactions Between Obeticholic Acid and Caffeine, Midazolam, Warfarin, Dextromethorphan, Omeprazole, Rosuvastatin, and Digoxin in Phase 1 Studies in Healthy Subjects

Analyte OCA 10 mg OCA 25 mg
AUEC E max AUEC E max
PT, n 21 21 22 22
GLSM ratio (90% CI) 0.967 (0.946–0.988) 0.888 (0.851–0.927) 0.981 (0.962–1.000) 0.927 (0.895–0.960)
aPPT, n 21 21 22 22
GLSM ratio (90% CI) 0.991 (0.978–1.004) 0.990 (0.976–1.005) 1.001 (0.980–1.022) 1.004 (0.975–1.034)
INR, n 21 21 22 22
GLSM ratio (90% CI) 0.967 (0.947–0.988) 0.889 (0.852–0.927) 0.982 (0.963–1.002) 0.928 (0.896–0.962)
  1. aPTT activated partial thromboplastin time, AUEC area under the effect curve for plasma pharmacodynamic measurements versus time from time zero to the last sampling collection time point (0–168 h), CI confidence interval, E max maximum observed effect, GLSM geometric least-squares mean, INR international normalized ratio, OCA obeticholic acid, PD pharmacodynamics, PK pharmacokinetic, PT prothrombin time