A Study of Sofosbuvir and Ledipasvir From Magicbuvir Plus 90/400 mg Tablets (Magic Pharma, Egypt) Versus Harvoni 90/400 mg Tablets (Gilead Sciences, USA)

Phase 1 Completed 37 enrolled Genuine Research Center, Egypt Magic Pharma, Egypt · 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 and Ledipasvir from Magicbuvir Plus 90/400 mg Tablets (Magic Pharma, Egypt) Versus Harvoni 90/400 mg Tablets (Gilead Sciences, Canada) in Healthy Human Volunteers Under Fed Condition.

Timeline

Start: 2016-11
Primary completion: 2016-11
Completion: 2016-12

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
Comparator	Ledipasvir	Small molecule	90 mg	—
Comparator	Sofosbuvir	Small molecule	400 mg	—

Indications

No indication recorded.