- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00759915
Comparison of Two KADIAN 10 mg Capsules to a KADIAN 20 mg Capsule Under Fed Conditions
August 13, 2010 updated by: Actavis Inc.
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 Fed 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, subjects consumed a standard high-calorie, high-fat breakfast meal that began 30 minutes prior to each dose.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78217
- CEDRA Clinical Research, LLC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 with spermicide 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 consume the entire high-calorie, high-fat breakfast meal in the designated timeframe required during each study period.
- 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 study drug 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 1
Treatment A (test product) followed by Treatment B (reference product)
|
2 x 10 mg, single-dose capsule
Other Names:
1 x 20 mg, single-dose capsule
Other Names:
|
Other: 2
Treatment B (reference product) followed by Treatment A (test product)
|
2 x 10 mg, single-dose capsule
Other Names:
1 x 20 mg, single-dose capsule
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
|
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 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,36,48 hrs
|
0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,36,48 hrs
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: James P. Doherty, DO, CEDRA Clinical Research, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (Actual)
September 1, 2006
Study Completion (Actual)
October 1, 2006
Study Registration Dates
First Submitted
September 24, 2008
First Submitted That Met QC Criteria
September 24, 2008
First Posted (Estimate)
September 25, 2008
Study Record Updates
Last Update Posted (Estimate)
August 17, 2010
Last Update Submitted That Met QC Criteria
August 13, 2010
Last Verified
August 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-072-SA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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