Mefloquine Bioequivalence Among 3 Commercially Available Tablets.
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Outcome Measures
Primary Outcome Measures
- Measure concentrations of mefloquine in blood to determine pharmacokinetic parameters and assess bioequivalence. [56 days]
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDC-NCZVED-3620
- DoD#31595