Mefloquine Bioequivalence Among 3 Commercially Available Tablets.

Completed

• Conditions: Malaria

• Registration Number: NCT00544024
• Lead Sponsor: Centers for Disease Control and Prevention

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.

Study Timeline

• Study Start: 2004-03
• Study Completion: 2007-03
• Status Verified: 2007-10
• Study First Submitted: 2007-10-12
• Study First Submitted QC: 2007-10-12
• Last Update Submitted: 2007-10-12
• Study First Posted: 2007-10-16
• Last Update Posted: 2007-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measure concentrations of mefloquine in blood to determine pharmacokinetic parameters and assess bioequivalence.	56 days

Trial Locations

Locations (1)

Apoyo Hospital; 🇵🇪 Iquitos, Peru