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Mefloquine Bioequivalence Among 3 Commercially Available Tablets.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00544024
First Posted: October 16, 2007
Last Update Posted: October 16, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Naval Medical Research Center
Universidad Peruana Cayetano Heredia
Ministry of Health, Lima Peru
Information provided by:
Centers for Disease Control and Prevention
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00544024


Locations
Peru
Apoyo Hospital
Iquitos, Peru
Sponsors and Collaborators
Centers for Disease Control and Prevention
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

ClinicalTrials.gov Identifier: NCT00544024     History of Changes
Other Study ID Numbers: CDC-NCZVED-3620
DoD#31595
First Submitted: October 12, 2007
First Posted: October 16, 2007
Last Update Posted: October 16, 2007
Last Verified: October 2007

Keywords provided by Centers for Disease Control and Prevention:
Mefloquine

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Mefloquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents


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