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NCT01010152 · ClinicalTrials.gov registry record · Phase 1

Comparative Bioavailability Study of Codeine Sulfate

A Phase 1 study, sponsored by Roxane Laboratories.

Completed
Registry status
Phase 1
Development phase
34
Enrollment target

NCT01010152: Completed Phase 1 study, sponsored by Roxane Laboratories.

NCT01010152 is a Phase 1 study that has completed, run by Roxane Laboratories. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01010152, a Phase 1 study, has completed, sponsored by Roxane Laboratories.

COMPLETED
Registry status
Phase 1
Development phase
34 participants
Enrollment target

Study Summary

The objective of this study was to assess the comparative bioavailability of codeine from Roxane Laboratories' Codeine Sulfate 30mg tablets to Tylenol® #3 (acetaminophen 300mg with codeine phosphate 30mg) under fasted conditions

Interventions

  • DRUG Codeine Sulfate

Trial Details

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

93 total trials

What the finished NCT01010152 record still lists

NCT01010152 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).

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

NCT01010152 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01010152 about?

NCT01010152 is a clinical study titled "Comparative Bioavailability Study of Codeine Sulfate". The objective of this study was to assess the comparative bioavailability of codeine from Roxane Laboratories' Codeine Sulfate 30mg tablets to Tylenol® #3 (acetaminophen 300mg with codeine phosphate 30mg) under fasted conditions

What is the current status of trial NCT01010152?

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 NCT01010152?

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

Who is sponsoring clinical trial NCT01010152?

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

How this trial's enrollment target compares

Where NCT01010152's enrollment target sits among peer trials

34 1273rd of 2000 higher than 721 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01010152, the US trial registry maintained by the National Library of Medicine. NCT01010152 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.