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NCT01009853 · ClinicalTrials.gov registry record · Phase 1

Steady State Study of Codeine Sulfate

A Phase 1 study, sponsored by Roxane Laboratories.

Completed
Registry status
Phase 1
Development phase
34
Enrollment target

NCT01009853 is a Phase 1 study that has completed, run by Roxane Laboratories. The registered enrollment target is 34 participants.

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The verdict

NCT01009853, a Phase 1 study, has completed, sponsored by Roxane Laboratories.

COMPLETED
Registry status
Phase 1
Development phase
34 participants
Enrollment target

Study Summary

Study to characterize the steady-state pharmacokinetics of codeine and its metabolites morphine, morphine-3-glucuronide (M3G), and morphine-6-glucuronide (M6G) after oral administration of Roxane Laboratories' codeine sulfate tablets administered at a dose of 15 mg Q4H x 5 days.

Interventions

  • DRUG Codeine Sulfate

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2008-01
Est. Completion 2008-01
Phase Phase 1

Sponsor

Roxane Laboratories

93 total trials

What the Registry Record Tells You About NCT01009853

The ClinicalTrials.gov registry entry for NCT01009853 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Roxane Laboratories, which has 93 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Codeine Sulfate is the first listed.

NCT01009853 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01009853 about?

NCT01009853 is a clinical study titled "Steady State Study of Codeine Sulfate". Study to characterize the steady-state pharmacokinetics of codeine and its metabolites morphine, morphine-3-glucuronide (M3G), and morphine-6-glucuronide (M6G) after oral administration of Roxane Laboratories' codeine sulfate tablets administered at a dose of 15 mg Q4H x 5 days.

What is the current status of trial NCT01009853?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2008-01. Estimated completion is 2008-01.

What interventions are being tested in trial NCT01009853?

The interventions under investigation include: Codeine Sulfate (DRUG).

Who is sponsoring clinical trial NCT01009853?

This trial is sponsored by Roxane Laboratories, which has 93 total clinical trials registered on ClinicalTrials.gov.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.