A Study to Compare the Relative Bioavailability of Two 200 Mg Tramadol Hydrochloride Tablet Products Under Fasting Conditions

This study has been completed.

Sponsor:

Information provided by:

Labopharm Inc.

ClinicalTrials.gov Identifier:

NCT00834366

First received: January 30, 2009

Last updated: April 25, 2012

Last verified: April 2012

History of Changes

Results First Received: April 6, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Open Label
Condition:	Healthy
Intervention:	Drug: Tramadol HCl

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Tramadol HCl 200 mg Film-coated Tablets	Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
Tramadol HCl 200 mg Uncoated Tablets	Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.

Participant Flow for 2 periods

Period 1: Treatment Period 1

	Tramadol HCl 200 mg Film-coated Tablets	Tramadol HCl 200 mg Uncoated Tablets
STARTED	13	13
COMPLETED	12	12
NOT COMPLETED	1	1
Adverse Event	1	1

Period 2: Treatment Period 2

	Tramadol HCl 200 mg Film-coated Tablets	Tramadol HCl 200 mg Uncoated Tablets
STARTED	12	12
COMPLETED	12	12
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Tramadol HCl 200 mg Film-coated Tablets	Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
Tramadol HCl 200 mg Uncoated Tablets	Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
Total	Total of all reporting groups

Baseline Measures

	Tramadol HCl 200 mg Film-coated Tablets	Tramadol HCl 200 mg Uncoated Tablets	Total
Number of Participants [units: participants]	13	13	26
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	13	13	26
>=65 years	0	0	0
Gender [units: participants]
Female	6	5	11
Male	7	8	15

Outcome Measures

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1. Primary:

AUC(0-t) [ Time Frame: 48 hours ]

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2. Primary:

AUC(0-Inf) [ Time Frame: 48 hours ]

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3. Primary:

Cmax [ Time Frame: 48 hours ]

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4. Secondary:

Tmax [ Time Frame: 48 hours ]

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5. Secondary:

t1/2 [ Time Frame: 48 hours ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: If a publication based on the results of this study is envisaged, approval from the sponsor will be obtained and a draft manuscript will be submitted to the sponsor for scrutiny and comment.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Director of Regulatory Affairs
Organization: Labopharm Inc.
phone: 1 450 686 1017

No publications provided

Responsible Party:	Sybil Robertson, Vice President, Regulatory Affairs, Labopharm Inc.
ClinicalTrials.gov Identifier:	NCT00834366 History of Changes
Other Study ID Numbers:	MDT1-013
Study First Received:	January 30, 2009
Results First Received:	April 6, 2009
Last Updated:	April 25, 2012
Health Authority:	United States: Food and Drug Administration South Africa: Medicines Control Council

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