Comparative Bioavailability Study of Codeine Sulfate

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-01-31

Brief Summary

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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

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Codeine Sulfate

30 mg tablet

Group Type EXPERIMENTAL

Codeine Sulfate

Intervention Type DRUG

30 mg Tablet

Tylenol #3

30 mg tablet

Group Type ACTIVE_COMPARATOR

Codeine Sulfate

Intervention Type DRUG

30 mg Tablet

Interventions

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Codeine Sulfate

30 mg Tablet

Intervention Type DRUG

Other Intervention Names

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Tylenol #3 Tablets

Eligibility Criteria

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Inclusion Criteria

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to codeine sulfate or any comparable or similar product.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes