Mefloquine Bioequivalence Among 3 Commercially Available Tablets.

Malaria Clinical Trial

Official title:

Mefloquine Bioequivalence Among Three Commercial Tablet Formulations in Peruvian Subjects With Uncomplicated Plasmodium Falciparum Malaria

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00544024
• Other study ID #: CDC-NCZVED-3620
• Secondary ID: DoD#31595
• Status: Completed
• Phase: N/A
• First received: October 12, 2007
• Last updated: October 12, 2007
• Start date: March 2004
• Est. completion date: March 2007

Study information

• Verified date: October 2007
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentPeru: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Malaria

Locations

Country	Name	City	State
Peru	Apoyo Hospital	Iquitos

Sponsors (4)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention	Ministry of Health, Lima Peru, Naval Medical Research Center, Universidad Peruana Cayetano Heredia

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure concentrations of mefloquine in blood to determine pharmacokinetic parameters and assess bioequivalence.		56 days