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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

September 24, 2008
August 13, 2010
August 2006
September 2006   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Plasma pharmacokinetic samples analyzed for morphine and morphine-6-glucoronide [ Time Frame: 48 hours post-dose ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00759902 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
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Comparison of Two KADIAN 10 mg Capsules to a KADIAN 20 mg Capsule Under Fasted Conditions
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Healthy
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
October 2006
September 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00759902
20-073-SA
Not Provided
Meena Venugopal, Director, Clinical R&D, Actavis Inc
Actavis Inc.
Not Provided
Principal Investigator: James P. Doherty, DO CEDRA Clinical Research, LLC
Actavis Inc.
August 2010

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