Pharmacokinetic and Comparative Bioavailability Study of Codeine Sulfate Under Fasted Conditions

• Sponsor: Roxane Laboratories (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01010139
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Duration (Months): 1
• Patients Per Site Per Month: 17.7

Study Details

Study Description

Brief Summary

The objective of this study designed to characterize the pharmacokinetics and comparative bioavailability of Roxane Laboratories' codeine sulfate tablets after oral administration of 60 mg doses as 1 x 60 mg, 2 x 30 mg and 4 x 15 mg under fasted conditions.

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: Codeine Sulfate	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Single Dose, 3-Period, 3-Treatment, 6-Sequence Crossover Pharmacokinetic and Comparative Bioavailability Study of Codeine Sulfate Tablet Formulations Under Fasting Conditions
• Study Start Date: Aug 1, 2006
• Actual Primary Completion Date: Sep 1, 2006
• Actual Study Completion Date: Sep 1, 2006

Outcome Measures

Primary Outcome Measures

1. bioequivalence determined by statistical comparison Cmax [21 Days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CEDRA Clinical Research	San Antonio	Texas	United States	78217

Sponsors and Collaborators

• Roxane Laboratories

Investigators

• Principal Investigator: James P Doherty, DO, CEDRA Clinical Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01010139
• Other Study ID Numbers: CODE-T60-PLFS-1
• First Posted: Nov 9, 2009
• Last Update Posted: Jan 23, 2018
• Last Verified: Jan 1, 2018

• Additional relevant MeSH terms: Codeine

Study Results

No Results Posted as of Jan 23, 2018