Accession Number : ADA331019

Title :   Phase 1 Clinical Pharmacology Studies.

Descriptive Note : Final rept. 1 Apr 90-31 Mar 97,

Corporate Author : SOUTH FLORIDA DRUG RESEARCH CORP MIAMI

Personal Author(s) : Lasseter, Kenneth C.

PDF Url : ADA331019

Report Date : SEP 1997

Pagination or Media Count : 11

Abstract : Six Phase I clinical pharmacology studies were performed during this contract period under the Task Order numbers 90-01, 92-04, 92-05, 94-06, 94-07 and 94-09. Task Order 90-01 produced data suggesting that the Mark I auto-injector produced effective and desirable blood levels and effects of atropine and 2-PAM compared to other prototype auto-injectors. Task Order 92-04 demonstrated that WR 238, 605 was safe and well tolerated at single doses up to 600 mg. Task Order 92-05 compared the blood levels produced by a new dosing regimen for halofantrine in the fed compared to the fasting state. Task Order 94-06 demonstrated the lack of irritating potential for a topical skin protectant. Task Order 94-07 demonstrated the safety of weekly dosing with the antimalarial WR 238, 605 and documented the accumulation of non toxic methemoglobin levels at the higher doses. This side effect may be beneficial in prophylaxis against cyanide poisoning. Task Order 94-09 showed a lack of toxicity from multiple dose pyridostigmine bromide in healthy male and female subjects of different weights.

Descriptors :   *PHARMACOLOGY, *PREVENTIVE MEDICINE, *PROTECTIVE TREATMENTS, TOXICITY, SAFETY, DOSAGE, LEVEL(QUANTITY), POISONING, CYANIDES, ACCUMULATION, SKIN(ANATOMY), PYRIDOSTIGMINE BROMIDE, METHEMOGLOBIN, BLOOD VOLUME, ATROPINE, FOOD DEPRIVATION.

Subject Categories : Medicine and Medical Research
      Pharmacology

Distribution Statement : APPROVED FOR PUBLIC RELEASE