Mefloquine Bioequivalence Among 3 Commercially Available Tablets. - Full Text View

Sponsors and Collaborators:	Centers for Disease Control and Prevention 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

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

MedlinePlus related topics: Malaria

Drug Information available for: Mefloquine Mefloquine hydrochloride

U.S. FDA Resources

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

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

Biospecimen Description:

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

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

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

Keywords provided by Centers for Disease Control and Prevention:

Mefloquine

Study placed in the following topic categories:

Protozoan Infections
Parasitic Diseases
Malaria
Mefloquine
Malaria, Falciparum

Additional relevant MeSH terms:

Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents

Coccidiosis
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009