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Malarone Pharmacokinetics Under Simulated Physiologic Stressors of Deployment

NCT03991208 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2021-04-30

No results posted yet for this study

Summary

A 2x2 randomized crossover of single dose malarone at rest and during moderate intensity exercise under controlled conditions of heat and humidity in healthy adult participants. Statistical analysis of AUC and Cmax will be performed to determine pharmacokinetic changes.

Conditions

  • Exercise
  • Pharmacokinetics

Interventions

DRUG

Malarone

Malarone

Sponsors & Collaborators

  • Walter Reed Army Institute of Research (WRAIR)

    lead FED

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-24
Primary Completion
2021-05-23
Completion
2021-05-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03991208 on ClinicalTrials.gov