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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00759902
Recruitment Status : Completed
First Posted : September 25, 2008
Results First Posted : September 1, 2009
Last Update Posted : August 17, 2010
Sponsor:
Information provided by:
Actavis Inc.

Tracking Information
First Submitted Date  ICMJE September 24, 2008
First Posted Date  ICMJE September 25, 2008
Results First Submitted Date  ICMJE December 5, 2008
Results First Posted Date  ICMJE September 1, 2009
Last Update Posted Date August 17, 2010
Study Start Date  ICMJE August 2006
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 21, 2009)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 24, 2008)
Plasma pharmacokinetic samples analyzed for morphine and morphine-6-glucoronide [ Time Frame: 48 hours post-dose ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2009)
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Two KADIAN 10 mg Capsules to a KADIAN 20 mg Capsule Under Fasted Conditions
Official Title  ICMJE A Randomized Two-way Crossover, Single-Dose, Open-Label Study to Evaluate the Bioequivalence of a Test Formulation of KADIAN (2 x 10mg) Capsules Compared to a KADIAN 20 mg Capsule in Healthy Adult Subjects Under Fasted Conditions
Brief Summary The objective of this single-dose, open-label, randomized, two-treatment, two-period crossover study was to compare the relative bioavailability of a test formulation of KADIAN (2 x 10 mg) capsules manufactured by Alpharma Inc. to an equivalent oral dose of the commercially available reference product, KADIAN (1 x 20 mg)capsules manufactured by Alpharma Branded Products Inc. following an overnight fast of at least 10 hours.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: morphine sulfate extended-release capsules
    2 x 10 mg, single-dose capsule
    Other Names:
    • Treatment A
    • Test product
  • Drug: KADIAN (morphine sulfate extended-release) capsules
    1 x 20 mg, single-dose capsule
    Other Names:
    • Treatment B
    • Reference product
Study Arms  ICMJE
  • 1
    Treatment A (test product) followed by Treatment B (reference product)
    Interventions:
    • Drug: morphine sulfate extended-release capsules
    • Drug: KADIAN (morphine sulfate extended-release) capsules
  • 2
    Treatment B (reference product) followed by Treatment A (test product)
    Interventions:
    • Drug: morphine sulfate extended-release capsules
    • Drug: KADIAN (morphine sulfate extended-release) capsules
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2008)
36
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2006
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject must be a male or non-pregnant, non-breast-feeding female.
  • Subject must be between 18 and 55 years of age (inclusive).
  • Subject's Body Mass Index (BMI) must be between 18 and 30 kg/m2 (inclusive), and subject must weigh a minimum of 50 kg (110 lbs).
  • Female subjects - not surgically sterile or at least two years postmenopausal - must agree to utilize one of the following forms of contraception, if sexually active with a male partner, at least from screening through completion of the study. Approved forms of contraception are abstinence, hormonal (oral, implant, transdermal or injection) in use at least 3 consecutive months prior to first dose of study medication, double barrier (condom and diaphragm with spermicide), intra-uterine device (IUD), or vasectomized partner (6 months minimum since vasectomy).
  • Subject must voluntarily consent to participate in this study and provide their written informed consent prior to completion of any study-specific procedures.
  • Subject is willing and able to remain in the study unit for the entire duration of each confinement period and return to the study site for all outpatient visits.

Exclusion Criteria:

  • History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic or psychiatric disease or any other condition which, in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results.
  • Has a clinically significant abnormal finding on the physical exam, medical history, ECG or clinical laboratory results at screening.
  • History or presence of allergic or adverse response to the KADIAN or related drugs.
  • Has been on a significantly abnormal diet during the four weeks preceding the first dose of study medication.
  • Has donated blood or plasma within 30 days prior to the first dose of study medication.
  • Has participated in another clinical trial within 30 days prior to first dose of study medication.
  • Has used any over-the-counter (OTC) medication including nutritional supplements, within 7 days prior to the first dose of study medication.
  • Has used any prescription medication, except hormonal contraceptive or hormonal replacement therapy, within 14 days prior to the first dose of study medication.
  • Has been treated with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, etc., within 30 days prior to the first dose of study medication.
  • Has smoked or used tobacco products within 60 days prior to the first dose of study medication.
  • Has a history of treatment for substance abuse (including alcohol) in the past 5 years.
  • Is a female with a positive pregnancy test result.
  • Has a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, opiates).
  • Has had a positive test for, or has been treated for Hepatitis B, Hepatitis C or HIV.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00759902
Other Study ID Numbers  ICMJE 20-073-SA
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Meena Venugopal, Director, Clinical R&D, Actavis Inc
Study Sponsor  ICMJE Actavis Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James P. Doherty, DO CEDRA Clinical Research, LLC
PRS Account Actavis Inc.
Verification Date August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP