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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


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.


Minimum age: N/A. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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