Comparison of Two KADIAN 10 mg Capsules to a KADIAN 20 mg Capsule Under Fasted Conditions

This study has been completed.

Sponsor:

Information provided by:

Actavis Inc.

ClinicalTrials.gov Identifier:

NCT00759902

First received: September 24, 2008

Last updated: August 13, 2010

Last verified: August 2010

History of Changes

Results First Received: December 5, 2008

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: morphine sulfate extended-release capsules Drug: KADIAN (morphine sulfate extended-release) capsules

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
Period 1: Treatment A or B	Treatment A (test product) followed by Treatment B (reference product)
Period 2: Treatment A or B	Treatment B (reference product) followed by Treatment A (test product)

Participant Flow: Overall Study

	Period 1: Treatment A or B	Period 2: Treatment A or B
STARTED	18	18
COMPLETED	18	17
NOT COMPLETED	0	1
Adverse Event	0	1

Baseline Characteristics

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Reporting Groups

	Description
Period 1: Treatment A or B	Treatment A (test product) followed by Treatment B (reference product)
Period 2: Treatment A or B	Treatment B (reference product) followed by Treatment A (test product)
Total	Total of all reporting groups

Baseline Measures

	Period 1: Treatment A or B	Period 2: Treatment A or B	Total
Number of Participants [units: participants]	18	18	36
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	18	18	36
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	31.6 ± 9.6	31.7 ± 8.9	31.7 ± 9.2
Gender [units: participants]
Female	10	10	20
Male	8	8	16
Region of Enrollment [units: participants]
United States	18	18	36

Outcome Measures

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1. Primary:

Maximum Plasma Morphine Concentration [ Time Frame: 0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs ]

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2. Secondary:

Time of Maximum Plasma Morphine Concentration [ Time Frame: 0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs ]

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3. Secondary:

Area Under the Curve to the Last Measurable Time Point for Plasma Morphine [ Time Frame: 0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs ]

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4. Secondary:

Area Under the Curve to Infinity for Plasma Morphine [ Time Frame: 0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,30,36,48 hrs ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
Additional Description	No text entered.

Frequency Threshold

Threshold above which other adverse events are reported	0%

Reporting Groups

	Description
Arm 1: Treatment A Followed by Treatment B	No text entered.
Arm 2: Treatment B Followed by Treatment A	No text entered.

Other Adverse Events

	Arm 1: Treatment A Followed by Treatment B	Arm 2: Treatment B Followed by Treatment A
Total, other (not including serious) adverse events
# participants affected	10	10
Cardiac disorders
Chest Pain ^{† 1}
# participants affected / at risk	1/18 (5.56%)	0/18 (0.00%)
# events	1	0
Palpitations ^{† 1}
# participants affected / at risk	1/18 (5.56%)	0/18 (0.00%)
# events	1	0
Gastrointestinal disorders
Nausea ^{† 1}
# participants affected / at risk	4/18 (22.22%)	3/18 (16.67%)
# events	4	3
Bowel ^{† 1}
# participants affected / at risk	1/18 (5.56%)	1/18 (5.56%)
# events	1	1
Constipation ^{† 1}
# participants affected / at risk	2/18 (11.11%)	0/18 (0.00%)
# events	2	0
Flatulence ^{† 1}
# participants affected / at risk	1/18 (5.56%)	0/18 (0.00%)
# events	1	0
Abdominal Pain ^{† 1}
# participants affected / at risk	1/18 (5.56%)	2/18 (11.11%)
# events	1	2
Vomiting ^{† 1}
# participants affected / at risk	0/18 (0.00%)	1/18 (5.56%)
# events	0	1
General disorders
Hunger ^{† 1}
# participants affected / at risk	0/18 (0.00%)	1/18 (5.56%)
# events	0	1
Infections and infestations
Genital Herpes ^{† 1}
# participants affected / at risk	0/18 (0.00%)	1/18 (5.56%)
# events	0	1
Musculoskeletal and connective tissue disorders
Musculoskeletal ^{† 1}
# participants affected / at risk	0/18 (0.00%)	1/18 (5.56%)
# events	0	1
Nervous system disorders
Headache ^{† 1}
# participants affected / at risk	3/18 (16.67%)	6/18 (33.33%)
# events	3	6
Dizziness ^{† 1}
# participants affected / at risk	1/18 (5.56%)	1/18 (5.56%)
# events	1	1
Paraesthesia ^{† 1}
# participants affected / at risk	1/18 (5.56%)	0/18 (0.00%)
# events	1	0
Psychiatric disorders
Abnormal Dreams ^{† 1}
# participants affected / at risk	0/18 (0.00%)	1/18 (5.56%)
# events	0	2
Reproductive system and breast disorders
Dysmenorrhea ^{† 1}
# participants affected / at risk	0/18 (0.00%)	1/18 (5.56%)
# events	0	1
Skin and subcutaneous tissue disorders
Pruritis ^{† 1}
# participants affected / at risk	1/18 (5.56%)	0/18 (0.00%)
# events	1	0
Skin Laceration ^{† 1}
# participants affected / at risk	0/18 (0.00%)	1/18 (5.56%)
# events	0	1
Skin Burning Sensation ^{† 1}
# participants affected / at risk	0/18 (0.00%)	1/18 (5.56%)
# events	0	1

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 10.0

More Information

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Certain Agreements:

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

There is NOT 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.

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: Meena Venugopal, Director, Clinical R&D
Organization: Actavis Inc.
phone: 908-659-2885
e-mail: MVenugopal@actavis.com

No publications provided

Responsible Party:	Meena Venugopal, Director, Clinical R&D, Actavis Inc
ClinicalTrials.gov Identifier:	NCT00759902 History of Changes
Other Study ID Numbers:	20-073-SA
Study First Received:	September 24, 2008
Results First Received:	December 5, 2008
Last Updated:	August 13, 2010
Health Authority:	United States: Food and Drug Administration

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