Mefloquine Bioequivalence Among 3 Commercially Available Tablets.

This study has been completed.
Sponsor:
Collaborators:
Naval Medical Research Center
Universidad Peruana Cayetano Heredia
Ministry of Health, Lima Peru
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00544024
First received: October 12, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

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.


Condition
Malaria

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mefloquine Bioequivalence Among Three Commercial Tablet Formulations in Peruvian Subjects With Uncomplicated Plasmodium Falciparum Malaria

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Measure concentrations of mefloquine in blood to determine pharmacokinetic parameters and assess bioequivalence. [ Time Frame: 56 days ]

Biospecimen Retention:   None Retained

Whole blood was obtained for analysis, but has been subsequently disposed after completion of drug analysis.


Enrollment: 39
Study Start Date: March 2004
Study Completion Date: March 2007
Groups/Cohorts
Reference
Lariam was administered as whole tablets with food and water at a dose of 25 mg/kg (15 mg/kg on the first day and 10mg/kg on the second day) along with artesunate at a dose of 4 mg/kg/day for three days under supervision by clinical staff
T1
Mephaquin was administered as whole tablets with food and water at a dose of 25 mg/kg (15 mg/kg on the first day and 10mg/kg on the second day) along with artesunate at a dose of 4 mg/kg/day for three days under supervision by clinical staff
T2
Mefloquine-AC Farma was administered as whole tablets with food and water at a dose of 25 mg/kg (15 mg/kg on the first day and 10mg/kg on the second day) along with artesunate at a dose of 4 mg/kg/day for three days under supervision by clinical staff

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00544024

Locations
Peru
Apoyo Hospital
Iquitos, Peru
Sponsors and Collaborators
Naval Medical Research Center
Universidad Peruana Cayetano Heredia
Ministry of Health, Lima Peru
Investigators
Principal Investigator: Michael D Green, PhD Centers for Disease Control and Prevention
Principal Investigator: Wilmer Marquino, MD Instituto Nacional de Salud, Lima, Peru
Principal Investigator: David Bacon, PhD Naval Medical Research Center Detachment
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00544024     History of Changes
Other Study ID Numbers: CDC-NCZVED-3620, DoD#31595
Study First Received: October 12, 2007
Last Updated: October 12, 2007
Health Authority: United States: Federal Government
Peru: Ministry of Health

Keywords provided by Centers for Disease Control and Prevention:
Mefloquine

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Mefloquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014