Accession Number:

ADA364323

Title:

Halofantrine Safety, Tolerance and Metabolism Studies.

Descriptive Note:

Final rept. 26 Jun 95-30 Jun 97

Corporate Author:

FOOD AND DRUG ADMINISTRATION ROCKVILLE MD

Report Date:

1997-10-01

Pagination or Media Count:

254.0

Abstract:

Halofantrine HCl is an antimalarial drug approved by the FDA for the treatment of mild to moderate malaria caused by Plasm odium falciparum or Plasm odium vivax1. The present study was designed to investigate the safety, tolerance and pharmacokinetics of halofantrine HCl given in multiple doses in a Phase I study as part of the overall development of halofantrine as a prophylactic antimalarial drug.

Subject Categories:

  • Microbiology
  • Pharmacology

Distribution Statement:

APPROVED FOR PUBLIC RELEASE