Mefloquine Bioequivalence Among 3 Commercially Available Tablets.
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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 |
- 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 |
|---|
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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
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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
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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 |
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.
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| Peru | |
| Apoyo Hospital | |
| Iquitos, Peru | |
| 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 October 17, 2012
