Clinical trial NCT00544024: Mefloquine Bioequivalence Among 3 Commercially Available Tablets.
Official title: Mefloquine Bioequivalence Among Three Commercial Tablet Formulations in Peruvian Subjects With Uncomplicated Plasmodium Falciparum Malaria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malaria
Keywords: Mefloquine
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: Naval Medical Research Center
name: Universidad Peruana Cayetano Heredia
name: Ministry of Health, Lima Peru
First posted: 2007-10-16
Enrollment: 39
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Thirty-nine adult subjects were initially enrolled in the study ranging in age from 18-61 years with a mean of 36 years. Seventy-two percent of the volunteer patients were male.

Brief 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.

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 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.

Primary outcomes:
measure: Measure concentrations of mefloquine in blood to determine pharmacokinetic parameters and assess bioequivalence.
timeFrame: 56 days
Secondary outcomes:
Other outcomes:
Locations:
city: Iquitos
country: Peru
facility: Apoyo Hospital
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Michael D Green, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional de Salud, Lima, Peru
name: Wilmer Marquino, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Naval Medical Research Center Detachment
name: David Bacon, PhD
role: PRINCIPAL_INVESTIGATOR
References: