Pentoxifylline Extended-Release Tablets 400 mg
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1 Pentoxifylline Extended-Release Tablets 4 mg COMPARATIVE BIOAVAILABILITY STUDIES APOTEX CORP.
2 Product: Pentoxifylline Extended-Release Tablets Approval Date: June 9, 1999 Indication: Description: treatment of patients with chronic occlusive peripheral vascular disease of the extremities white, oval, unscored, film-coated tablets, imprinted with "APO 33" on one side and plain on the other side COMPARATIVE BIOAVAILABILITY STUDIES OF APOTEX CORP. PENTOXIFYLLINE EXTENDED-RELEASE AND TRENTAL 4 mg TABLETS Study Design: Fasting Biostudy: Food Effect Biostudy: Steady State Biostudy: Standard 2-way cross-over bioavailability study Standard 3-way cross-over bioavailability study Standard 2-way cross-over steady state study Subjects: Normal human volunteers Normal human volunteers Normal human volunteers Number: 37 Number: 16 Number: 24 Mean Age: 28.3 years Mean Age: 27.8 years Mean Age: 32.3 years Mean Weight: lbs Mean Weight: 16.4 lbs Mean Weight: lbs Dose Administered: 4 mg (1 tablet) 4 mg (1 tablet) 4 mg (1 tablet) at, 8, 16, 24, 32, 4, 48, 56, 64, 72, 8, 88, and 96 hours Sampling At:,.33,.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 4.5, 5, 6, 8, 1, 12, 15, 18, 21, and 24 hours,.33,.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.5, 4, 4.5, 5, 6, 8, 1, 12, 15, 18, 21, and 24 hours Assay Method: LC/MS/MS LC/MS/MS LC/MS/MS Washout Time: 1 week 1 week 1 week, 24, 48, 72, 96, 96.25, 96.5, 97, 97.5, 98, 98.5, 99, 99.5, 1, 11, 12, 13, 14, 16, 18, 111, 114, and 12 hours
3 FASTING BIOSTUDY Pentoxifylline 9% Confidence Intervals * AUC -inf (ng hr / ml) (36.) (39.8) AUC -T (ng hr / ml) (45.9) (44.2) Cmax (ng / ml) (47.8) (42.3) Pentoxifylline 9% Confidence Intervals * AUC -inf (ng hr / ml) (37.9) (4.5) AUC -T (ng hr / ml) (38.1) (42.4) Cmax (ng / ml) (4.8) 41.5 (44.1) Pentoxifylline 9% Confidence Intervals * AUC -inf (ng hr / ml) (27.2) (27.7) AUC -T (ng hr / ml) (23.6) (27.8) Cmax (ng / ml) (25.9) (31.4)
4 FOOD EFFECT BIOSTUDY AUC -T (ng hr/ml) (74.2) (72.1) (72.8) 1. Cmax (ng/ml) (77.8) (72.) (14.2).86 AUC -T (ng hr/ml) (69.1) (73.1) (73.9) 1.3 Cmax (ng/ml) (71.8) (71.2) (87.3).87 AUC -T (ng hr/ml) (23.7) (31.1) (28.) 1.1 Cmax (ng/ml) (32.6) (36.7) (33.1)
5 STEADY STATE BIOSTUDY 9% Confidence Intervals * AUC (ng hr/ml) 62.7 (41.8) (42.7) Cmax (ng/ml) (51.5) (55.3) % Confidence Intervals * AUC (ng hr/ml) (35.1) (33.7) Cmax (ng/ml) (38.2) (33.2) % Confidence Intervals * AUC (ng hr/ml) (27.7) (23.5) Cmax (ng/ml) (28.3) (22.)
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