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Trial record 80 of 1411 for:    Peru

Mefloquine Bioequivalence Among 3 Commercially Available Tablets.

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ClinicalTrials.gov Identifier: NCT00544024
Recruitment Status : Completed
First Posted : October 16, 2007
Last Update Posted : October 16, 2007
Sponsor:
Collaborators:
Naval Medical Research Center
Universidad Peruana Cayetano Heredia
Ministry of Health, Lima Peru
Information provided by:
Centers for Disease Control and Prevention

Tracking Information
First Submitted Date October 12, 2007
First Posted Date October 16, 2007
Last Update Posted Date October 16, 2007
Study Start Date March 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: October 12, 2007)
Measure concentrations of mefloquine in blood to determine pharmacokinetic parameters and assess bioequivalence. [ Time Frame: 56 days ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Mefloquine Bioequivalence Among 3 Commercially Available Tablets.
Official Title Mefloquine Bioequivalence Among Three Commercial Tablet Formulations in Peruvian Subjects With Uncomplicated Plasmodium Falciparum Malaria
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   None Retained
Description:
Whole blood was obtained for analysis, but has been subsequently disposed after completion of drug analysis.
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.
Condition Malaria
Intervention Not Provided
Study 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 12, 2007)
39
Original Actual Enrollment Same as current
Actual Study Completion Date March 2007
Primary Completion Date Not Provided
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Peru
Removed Location Countries  
 
Administrative Information
NCT Number NCT00544024
Other Study ID Numbers CDC-NCZVED-3620
DoD#31595
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Centers for Disease Control and Prevention
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
PRS Account Centers for Disease Control and Prevention
Verification Date October 2007