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NCT02708992 · ClinicalTrials.gov registry record · Phase 1

Cefixime / Azithromycin pK Study

A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
10
Enrollment target

NCT02708992 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 10 participants.

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The verdict

NCT02708992, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
10 participants
Enrollment target

Study Summary

This is a PK study of a multi-dose oral cefixime regimen (three 800 mg doses given on a q 8-hour schedule) alone and also co administered with a single 1000 mg oral dose of azithromycin, both within a 24-hour period, in order to achieve total serum cefixime levels of mcg/mL for at least 20 hours. This will determine the tolerability of the regimen and whether there are significant changes in cefixime PK after co-administration. The primary pharmacokinetic objectives are: to determine if a cefixime dosing regimen of three 800 mg doses given alone, on a q 8-hour schedule achieves a total serum cefixime level that exceeds 2.0 mcg/mL for at least 20 hours; to determine if a cefixime dosing regimen of three 800 mg doses given on a q 8 hour schedule co-administered with a single 1000 mg of azithromycin, achieves a total serum cefixime level that exceeds 2.0 mcg/mL for at least 20 hours; and to evaluate whether a single 1000 mg dose of azithromycin alters the PK of a three dose regimen of 800

Interventions

  • DRUG Azithromycin
  • DRUG Cefixime

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2016-04-28
Est. Completion 2017-07-31
Phase Phase 1

What the Registry Record Tells You About NCT02708992

The ClinicalTrials.gov registry entry for NCT02708992 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Azithromycin is the first listed.

NCT02708992 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02708992 about?

NCT02708992 is a clinical study titled "Cefixime / Azithromycin pK Study". This is a PK study of a multi-dose oral cefixime regimen (three 800 mg doses given on a q 8-hour schedule) alone and also co administered with a single 1000 mg oral dose of azithromycin, both within a 24-hour period, in order to achieve total serum cefixime levels of mcg/mL for at least 20 hours. Th...

What is the current status of trial NCT02708992?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2016-04-28. Estimated completion is 2017-07-31.

What interventions are being tested in trial NCT02708992?

The interventions under investigation include: Azithromycin (DRUG), Cefixime (DRUG).

Who is sponsoring clinical trial NCT02708992?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

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

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