A Dose Linearity Study of the Labopharm Formulation of Tramadol HCl/Contramid®, 100 mg, 200 mg and 300 mg After A Single Oral Administration In Fasting Condition, In Healthy Human Volunteers

This study has been completed.

Sponsor:

Information provided by:

Labopharm Inc.

ClinicalTrials.gov Identifier:

NCT00834808

First received: January 30, 2009

Last updated: April 24, 2012

Last verified: April 2012

History of Changes

Results First Received: April 8, 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
1: Tramadol HCl 100mg	Single oral administration fasting conditions. Randomization schedule based on a Latin Square design.
2: Tramadol HCl 200mg	Single oral administration fasting conditions. Randomization schedule based on a Latin Square design.
3: Tramadol HCl 300mg	Single oral administration fasting conditions. Randomization schedule based on a Latin Square design.

Participant Flow for 3 periods

Period 1: Treatment Period 1 (Day 1)

	1: Tramadol HCl 100mg	2: Tramadol HCl 200mg	3: Tramadol HCl 300mg
STARTED	9	9	9
COMPLETED	9	9	9
NOT COMPLETED	0	0	0

Period 2: Treatment Period 2 (Day 8)

	1: Tramadol HCl 100mg	2: Tramadol HCl 200mg	3: Tramadol HCl 300mg
STARTED	9	9	9
COMPLETED	9	9	9
NOT COMPLETED	0	0	0

Period 3: Treatment Period 3 (Day 15)

	1: Tramadol HCl 100mg	2: Tramadol HCl 200mg	3: Tramadol HCl 300mg
STARTED	9	9	9
COMPLETED	9	9	9
NOT COMPLETED	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
1: Tramadol HCl 100mg	Single oral administration fasting conditions. Randomization schedule based on a Latin Square design.
2: Tramadol HCl 200mg	Single oral administration fasting conditions. Randomization schedule based on a Latin Square design.
3: Tramadol HCl 300mg	Single oral administration fasting conditions. Randomization schedule based on a Latin Square design.
Total	Total of all reporting groups

Baseline Measures

	1: Tramadol HCl 100mg	2: Tramadol HCl 200mg	3: Tramadol HCl 300mg	Total
Number of Participants [units: participants]	9	9	9	27
Age [units: participants]
<=18 years	0	0	0	0
Between 18 and 65 years	9	9	9	27
>=65 years	0	0	0	0
Gender [units: participants]
Female	0	0	0	0
Male	9	9	9	27

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: The publication of the results obtained will be authorized, after prior agreement between the various recipients [investigator and sponsor].

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

Publications of Results:

Karhu D, El-Jammal A, Dupain T, Gaulin D, Bouchard S. Pharmacokinetics and dose proportionality of three Tramadol Contramid OAD tablet strengths. Biopharm Drug Dispos. 2007 Sep;28(6):323-30.

Responsible Party:	Vice-President Regulatory Affairs, Labopharm Inc.
ClinicalTrials.gov Identifier:	NCT00834808 History of Changes
Other Study ID Numbers:	MDT1-011
Study First Received:	January 30, 2009
Results First Received:	April 8, 2009
Last Updated:	April 24, 2012
Health Authority:	United States: Food and Drug Administration France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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