Bioequivalence Study of Colchicine Tablets

This study has been completed.

Sponsor:

Information provided by:

Mutual Pharmaceutical Company, Inc.

ClinicalTrials.gov Identifier:

NCT01021020

First received: August 12, 2009

Last updated: December 1, 2009

Last verified: December 2009

History of Changes

Results First Received: August 12, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Bio-equivalence Study; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Basic Science
Condition:	Healthy
Interventions:	Drug: Colchicine Drug: Colchicine/Probenecid

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
Twenty-eight (28) healthy, non-smoking, adult male and female volunteers, consisting of university students and members of the community at large, were to be enrolled.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
75 subjects screened, 47 were screen failures

Reporting Groups

	Description
Colchicine (Fasted),Colchicine (Fed),Colchicine/Probenecid	All subjects received each of the three study treatments in a randomly assigned sequence of dosing periods. On the morning of Days 1, 15, and 29, each subject received one of the following three treatments: 1) one tablet of colchicine 0.6 mg after an overnight fast of at least 13.5 hours, 2) one tablet of colchicine 0.6 mg after a high-fat breakfast, or 3) one tablet of colchicine 0.5 mg/ probenecid 500 mg following an overnight fast of at least 13.5 hours.

Description

Colchicine (Fasted),Colchicine (Fed),Colchicine/Probenecid

All subjects received each of the three study treatments in a randomly assigned sequence of dosing periods. On the morning of Days 1, 15, and 29, each subject received one of the following three treatments: 1) one tablet of colchicine 0.6 mg after an overnight fast of at least 13.5 hours, 2) one tablet of colchicine 0.6 mg after a high-fat breakfast, or 3) one tablet of colchicine 0.5 mg/ probenecid 500 mg following an overnight fast of at least 13.5 hours.

Participant Flow for 5 periods

Period 1: Period I

	Colchicine (Fasted),Colchicine (Fed),Colchicine/Probenecid
STARTED	28
COMPLETED	26 ^[1]
NOT COMPLETED	2
Protocol Violation	1
Withdrawal by Subject	1

[1]	Colchicine(fasted)-subject took Claritin-D 12hour.Colchicine(fed)arm-subject had schedule conflict.

Period 2: 14 Day Washout Period A

	Colchicine (Fasted),Colchicine (Fed),Colchicine/Probenecid
STARTED	26
COMPLETED	25 ^[1]
NOT COMPLETED	1
Physician Decision	1

[1]	Colchicine/Probenecid-medical investigator dropped due to abnormal check-in lab results.

Period 3: Period II

	Colchicine (Fasted),Colchicine (Fed),Colchicine/Probenecid
STARTED	25
COMPLETED	25
NOT COMPLETED	0

Period 4: 14 Day Washout Period B

	Colchicine (Fasted),Colchicine (Fed),Colchicine/Probenecid
STARTED	25
COMPLETED	25
NOT COMPLETED	0

Period 5: Period III

	Colchicine (Fasted),Colchicine (Fed),Colchicine/Probenecid
STARTED	25
COMPLETED	25
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Colchicine(Fasted),Colchicine(Fed),Colchicine/Probenecid	All subjects received all study treatments in a randomly assigned sequence of dosing periods. On the morning of Days 1, 15, and 29, each subject received one of the following three treatments: 1) one tablet of colchicine 0.6 mg after an overnight fast of at least 13.5 hours, 2) one tablet of colchicine 0.6 mg after a high-fat breakfast, or 3) one tablet of colchicine 0.5 mg/ probenecid 500 mg following an overnight fast of at least 13.5 hours.

Description

Colchicine(Fasted),Colchicine(Fed),Colchicine/Probenecid

All subjects received all study treatments in a randomly assigned sequence of dosing periods. On the morning of Days 1, 15, and 29, each subject received one of the following three treatments: 1) one tablet of colchicine 0.6 mg after an overnight fast of at least 13.5 hours, 2) one tablet of colchicine 0.6 mg after a high-fat breakfast, or 3) one tablet of colchicine 0.5 mg/ probenecid 500 mg following an overnight fast of at least 13.5 hours.

Baseline Measures

	Colchicine(Fasted),Colchicine(Fed),Colchicine/Probenecid
Number of Participants [units: participants]	28
Age ^[1] [units: participants]
<=18 years	0
Between 18 and 65 years	28
>=65 years	0
Age [units: years] Mean ± Standard Deviation	23.7 ± 5.7
Gender [units: participants]
Female	18
Male	10
Race (NIH/OMB) [units: participants]
American Indian or Alaska Native	1
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	2
White	24
More than one race	0
Unknown or Not Reported	1
Region of Enrollment [units: participants]
United States	28

[1]	age range: >=18 and <=45 years old

Outcome Measures

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1. Primary:

Maximal Plasma Concentration (Cmax) [ Time Frame: serial pharmacokinetic blood samples collected pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose ]

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2. Primary:

Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] [ Time Frame: serial pharmacokinetic blood samples collected pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose ]

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3. Primary:

Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] [ Time Frame: serial pharmacokinetic blood samples collected pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours post-dose ]

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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.

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
No text entered.

Results Point of Contact:

Name/Title: Medical Affairs Director
Organization: Mutual Pharmaceutical Company, Inc.
phone: 215-697-1743
e-mail: clinicaltrials@urlmutual.com

No publications provided

Responsible Party:	Vice President, Branded Products and Medical Affairs, Mutual Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier:	NCT01021020 History of Changes
Other Study ID Numbers:	MPC-004-07-1001
Study First Received:	August 12, 2009
Results First Received:	August 12, 2009
Last Updated:	December 1, 2009
Health Authority:	United States: Food and Drug Administration

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