Ignite Creation Date:
2024-05-05 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00544024
Status:
COMPLETED
Last Update Posted:
2007-10-16
First Post:
2007-10-12
Brief Title:
Mefloquine Bioequivalence Among 3 Commercially Available Tablets
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Mefloquine Bioequivalence Among Three Commercial Tablet Formulations in Peruvian Subjects With Uncomplicated Plasmodium Falciparum Malaria
Status:
COMPLETED
Status Verified Date:
2007-10
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:
The objective of this study was to determine the bioequivalence among three commercial tablet formulations of MQ ie Lariam Mephaquin and Mefloquine-AC Farma when given in combination with artesunate
Detailed Description:
Pharmacokinetic parameters were determined for mefloquine in whole blood from Peruvian subjects with uncomplicated falciparum malaria administered Mephaquin Mefloquine-AC Farma and Lariam The Mefloquine-AC Farma arm comprised 13 patients while the reference Lariam and Mephaquin arms consisted of 12 patients Although Cmax was significantly less p004 in the Mephaquin arm AUC0-t 2500 ngmlday relative to the reference AUC0-t 2820 ngmlday arm there were no significant differences in the AUC tmax and t12 for Mefloquine-AC Farma or Mephaquin relative to the reference Except for the Cmax of the Mefloquine-AC Farma the 90 confidence intervals for all parameters of both treatments were outside the specified FDA range of 80-125 Therefore both formulations were not considered bioequivalent to the reference
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DoD31595 | None | None | None |