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Safety, Tolerability and PK of Single and Multiple Doses of Oxantel Pamoate Tablets

NCT06606860 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-08-28

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the safety, tolerability and pharmacokinetics of oxantel pamoate tablet after administration of a single and multiple dose in healthy male and female adult volunteers.

The main questions aim to answer if oxantel pamoate is safe and well tolerated in healthy volunteers and if is it absorbed by the human body.

A single dose and a multiple dose of oxantel pamoate will be compared to placebo to see if there are any different effects.

Conditions

  • Healthy

Interventions

DRUG

Oxantel Pamoate

Oxantel Pamoate tablet, 250mg

DRUG

Placebo

Placebo tablet

Sponsors & Collaborators

  • Ifakara Health Institute

    collaborator OTHER

  • Drugs for Neglected Diseases initiative

    collaborator UNKNOWN

  • Swiss Tropical & Public Health Institute

    lead OTHER

Principal Investigators

  • Daniel Paris, MD, PhD · Swiss Tropical & Public Health Institute

  • Jennifer Keiser, PhD · Swiss Tropical & Public Health Institute

  • Hussein Mbarak, MD · Ifakara Health Insitute, Tanzania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-01-27
Primary Completion
2025-04-08
Completion
2025-04-08

Countries

  • Tanzania

Study Locations

More Related Trials

Entities

Drugs

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 NCT06606860 on ClinicalTrials.gov