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NCT00746499 · ClinicalTrials.gov registry record · Phase 1

Pharmacokinetic Study of Raltegravir in Healthy Premenopausal Women.

A Phase 1 study of Pharmacokinetics, sponsored by University of North Carolina, Chapel Hill.

Completed
Registry status
Phase 1
Development phase
7
Enrollment target
1
Study location

NCT00746499 is a Phase 1 study of Pharmacokinetics that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 7 participants, below the 62-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00746499, a Phase 1 study of Pharmacokinetics, has completed, sponsored by University of North Carolina, Chapel Hill.

COMPLETED
Registry status
Phase 1
Development phase
7 participants
Enrollment target
1
Study location

Study Summary

Healthy subjects will take study drug by mouth twice a day for 7 consecutive days, blood and cervicovaginal samples will be taken most mornings around the AM dose. Two visits, \~14 hrs in length will be required on Day 1 and 7. The purpose of this study is to measure how much raltegravir is found in the genital tract after taking it orally.

Conditions Studied

Interventions

  • DRUG Raltegravir

Study Locations (1)

North Carolina

  • University of North Carolina - Chapel Hill

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2008-09
Est. Completion 2008-11
Phase Phase 1

What the Registry Record Tells You About NCT00746499

The ClinicalTrials.gov registry entry for NCT00746499 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 62-participant average among 37 other Pharmacokinetics trials with a reported enrollment target (89% lower). The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Pharmacokinetics appearing as the primary indexed condition, and to 1 intervention - of which Raltegravir is the first listed.

NCT00746499 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT00746499 about?

NCT00746499 is a clinical study titled "Pharmacokinetic Study of Raltegravir in Healthy Premenopausal Women.". Healthy subjects will take study drug by mouth twice a day for 7 consecutive days, blood and cervicovaginal samples will be taken most mornings around the AM dose. Two visits, \~14 hrs in length will be required on Day 1 and 7. The purpose of this study is to measure how much raltegravir is found in...

What is the current status of trial NCT00746499?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2008-09. Estimated completion is 2008-11.

What conditions does trial NCT00746499 study?

This clinical trial studies the following conditions: Pharmacokinetics.

What interventions are being tested in trial NCT00746499?

The interventions under investigation include: Raltegravir (DRUG).

Who is sponsoring clinical trial NCT00746499?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00746499 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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