MedTrace Logo

Open Label Pharmacokinetic Study of OZ439 and Piperaquine on Administration of OZ439+TPGS Granules for Oral Suspension Alone or With Either Piperaquine Phosphate Tablets or Granules for Oral Solution in Healthy Volunteers

NCT01958619 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2015-05-08

Study results available
· View outcomes & findings →

Summary

A healthy volunteer study to characterise the exposure of the two study medications, following administration of OZ439 + TPGS granules with piperaquine phosphate granules (intended for children) and with piperaquine phosphate tablets (intended for adults). Ideally, to confirm the exposure demonstrated in an earlier bioavailability study.

Conditions

Interventions

DRUG

1440mg PQP tablets

Piperaquine phosphate tablets (1440mg)

DRUG

960mg PQP tablets

Piperaquine phosphate tablets (960mg)

DRUG

800mg OZ439 + TPGS

OZ439 (800mg) + TPGS granules for oral suspension

DRUG

960mg PQP granules

Piperaquine phosphate granules for oral solution (960mg)

Sponsors & Collaborators

  • Richmond Pharmacology Limited

    collaborator INDUSTRY

  • Medicines for Malaria Venture

    lead OTHER

Principal Investigators

  • Ulrike Lorch, MD FRCA FFPM · Richmond Pharmacology Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT01958619 on ClinicalTrials.gov