Mefloquine Bioequivalence Among 3 Commercially Available Tablets.
Information source: Centers for Disease Control and Prevention
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malaria
Phase: N/A
Status: Completed
Sponsored by: Centers for Disease Control and Prevention Official(s) and/or principal investigator(s):
Michael D Green, PhD, Principal Investigator, Affiliation: Centers for Disease Control and Prevention
Wilmer Marquino, MD, Principal Investigator, Affiliation: Instituto Nacional de Salud, Lima, Peru
David Bacon, PhD, Principal Investigator, Affiliation: Naval Medical Research Center Detachment
Summary
The objective of this study was to determine the bioequivalence among three commercial
tablet formulations of MQ, i. e. Lariam, Mephaquin, and Mefloquine-(AC Farma) when given in
combination with artesunate.
Clinical Details
Official title: Mefloquine Bioequivalence Among Three Commercial Tablet Formulations in Peruvian Subjects With Uncomplicated Plasmodium Falciparum Malaria
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Measure concentrations of mefloquine in blood to determine pharmacokinetic parameters and assess bioequivalence.
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 (p=0. 04)
in the Mephaquin arm (AUC0-t = 2500 ng/ml/day) relative to the reference (AUC0-t = 2820
ng/ml/day) arm, there were no significant differences in the AUC∞, tmax, and t1/2 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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- The inclusion criteria for enrolling patients included; male or non-pregnant female ≥
18 years of age, infection with P. falciparum alone, with a parasite density between
250 and 50,000 asexual parasites/mm3 as determined by microscopic examination of a
thick blood smear, informed consent from patient, and a willingness to be
hospitalized for the first 24 hours after therapy is initiated and to return for
follow-up visits through day 56.
Exclusion Criteria:
- Patients exhibiting evidence of severe malaria or with a history of an underlying
chronic disease or illness that could interfere with the absorption of MQ, a history
of hypersensitivity to MQ, or a history of neuropsychiatric illness or cardiac
conduction problems were excluded.
Locations and Contacts
Apoyo Hospital, Iquitos, Peru
Additional Information
Starting date: March 2004
Last updated: October 12, 2007
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