A Bio-equivalence Study of Sofosbuvir From Elbanovir 400 mg Film Coated Tablets ( Multi-Apex Pharma, Egypt) & Sovaldi 400 mg Film Coated Tablets (Gilead Sciences, United Kingdom)

Phase 1 Completed 24 enrolled Genuine Research Center, Egypt Multi-Apex Pharma · collab

RandomizedCrossoverOpen-label

Summary

Comparative randomized, single dose, three way three sequence two treatment partial replicate crossover open-label study to determine the bioequivalence of Sofosbuvir from Elbanovir 400 mg Film Coated Tablets ( Multi-Apex Pharmaceutical industries, Egypt) versus Sovaldi 400 mg Film Coated Tablets (Gilead Sciences International Ltd. Cambridge, United Kingdom)

Timeline

Start: 2015-08
Primary completion: 2015-09
Completion: 2015-10

Publications

Background Chow SC, Wang H. On sample size calculation in bioequivalence trials. J Pharmacokinet Pharmacodyn. 2001 Apr;28(2):155-69. doi: 10.1023/a:1011503032353.
Background Diletti E, Hauschke D, Steinijans VW. Sample size determination for bioequivalence assessment by means of confidence intervals. Int J Clin Pharmacol Ther Toxicol. 1991 Jan;29(1):1-8.
Background Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987 Dec;15(6):657-80. doi: 10.1007/BF01068419.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sofosbuvir	Small molecule	400 mg	—

Indications

No indication recorded.