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NCT06263582 · OUTCOME

To Determine the Apparent Clearance (CL/F) of Artesunate (AS)

Pharmacokinetics of Intravaginal, Self-administered Artesunate Vaginal Pessaries Among Women in Kenya · Source last updated 2025-08-19

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
Day 5

What was measured

To determine the apparent clearance (CL/F) of Artesunate (AS) following five consecutive days of self-administration of 200mg Artesunate vaginal inserts (pessaries) among healthy women. Mean Artesunate clearance (L/Kg/hr) will be submitted.

Analysis population: The plasma apparent clearance (CL/F) of Artesunate could not be estimated because the concentration versus time profiles of both forms did not reach an elimination phase (i.e., the concentration versus time profile did not decrease) from 0 to 8h post administration of intravaginal artesunate.

Groups in this outcome

Artesunate Vaginal Inserts/ Pessaries

Artesunate vaginal inserts/pessaries are used as a treatment for cervical precancerous lesions. Artesunate pessary: Subjects will use the study pessaries, placed in the vagina every day for 5 consecutive days.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Artesunate Vaginal Inserts/ Pessaries0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
To determine the apparent clearance (CL/F) of Artesunate (AS) following five consecutive days of self-administration of 200mg Artesunate vaginal inserts (pessaries) among healthy women. Mean Artesunate clearance (L/Kg/hr) will be submitted.
groups
  1. description
    Artesunate vaginal inserts/pessaries are used as a treatment for cervical precancerous lesions. Artesunate pessary: Subjects will use the study pessaries, placed in the vagina every day for 5 consecutive days.
    id
    OG000
    title
    Artesunate Vaginal Inserts/ Pessaries
population Description
The plasma apparent clearance (CL/F) of Artesunate could not be estimated because the concentration versus time profiles of both forms did not reach an elimination phase (i.e., the concentration versus time profile did not decrease) from 0 to 8h post administration of intravaginal artesunate.
reporting Status
POSTED
time Frame
Day 5
title
To Determine the Apparent Clearance (CL/F) of Artesunate (AS)
type
SECONDARY

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice