Accession Number : ADA332082

Title :   Phase I Evaluation of Desbutyihalofantrine in Healthy Volunteers.

Descriptive Note : Annual rept. 15 Sep 96-14 Sep 97,

Corporate Author : GEORGETOWN UNIV WASHINGTON DC

Personal Author(s) : Abernethy, Darrell R.

PDF Url : ADA332082

Report Date : SEP 1997

Pagination or Media Count : 105

Abstract : The study design was a randomized, double-blind, placebo-controlled Phase I safety and tolerance study. Twenty-one healthy volunteers were randomly assigned to receive halofantrine or placebo. initially it was planned to study 16 subjects, with 12 subjects to receive active drug (halofantrine) and 4 subjects to receive placebo, however due to subject drop outs prior to study completion, the number to be enrolled was increased to increase the number of subjects who completed the entire study. The blind was maintained with the increase in sample size accomplished by stratified randomization. Subjects were dosed daily for 42 days with 500 mg halofantrine hydrochloride. Subjects fasted for at least 2 hours prior to and 2 hours following the oral dose. The initial 21 days of drug administration were done with subjects confined as inpatients to the the Georgetown University Medical Center Clinical Research Center and the remaining 21 days of drug administration the subject reported daily to the Clinical Research Center for medical assessment and supervised drug administration. The subjects were then followed periodically for the next 4 1/2 months with medical assessments and pharmacokinetic sampling at the Clinical Research Center.

Descriptors :   *PHARMACOKINETICS, *DRUGS, TEST AND EVALUATION, CLINICAL MEDICINE, RESEARCH FACILITIES, SAMPLING, SAFETY, DOSAGE, MALARIA, PLACEBOS, TOLERANCES(PHYSIOLOGY), ANTIMALARIALS, ORAL INTAKE.

Subject Categories : Pharmacology
      Organic Chemistry

Distribution Statement : APPROVED FOR PUBLIC RELEASE