Ignite Creation Date:
2024-05-06 @ 7:18 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02507648
Status:
COMPLETED
Last Update Posted:
2015-07-24
First Post:
2015-07-22
Brief Title:
A Bioequivalence Study of Oseltamivir From Oseltamivir 75 mg Caps Pharmacare PLC Palestine and Tamiflu 75 mg Caps Hoffmann-La Roche Switzerland
Sponsor:
Genuine Research Center Egypt
Organization:
Genuine Research Center Egypt
Study Overview
Official Title:
Comparative Open-labelRandomized Fasting Single Dose Two-way Crossover Bioequivalence Study of Oseltamivir From Oseltamivir 75 mg Caps Pharmacare PLC Palestine and Tamiflu 75 mg Caps Hoffmann-La Roche Switzerland
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Comparative randomized single dose two-way crossover open-label study to determine the bioequivalence of Oseltamivir from Oseltamivir 75 mg capsules Pharmacare PLC Palestine and Tamiflu 75 mg capsules Hoffmann-La Roche Switzerland under license Gilead Sciences California USA after a single oral dose administration of each to healthy adults under fasting conditions
Detailed Description:
Primary Pharmacokinetic Parameters Cmax Area under cover AUC0t and AUC0 Secondary Pharmacokinetic Parameters Ke tmax and t12e ANOVA using 5 significance level for transformed with the 90 confidence intervals and untransformed data of Cmax AUC0t and AUC0 and for untransformed data of Ke tmax and t12e The confidence intervals of logarithmically transformed TestReference ratios for Cmax AUC0t and AUC0 to be within 8000-12500
A comprehensive final report will be issued upon the completion of the study
A comprehensive final report will be issued upon the completion of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None