Clinical trial NCT00759915: Comparison of Two KADIAN 10 mg Capsules to a KADIAN 20 mg Capsule Under Fed Conditions
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: 10 mg
KADIAN capsules
20 mg
fed conditions
bioequivalence
Lead sponsor: Actavis Inc.
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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, subjects consumed a standard high-calorie, high-fat breakfast meal that began 30 minutes prior to each dose.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Plasma Morphine Concentration
timeFrame: 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 outcomes:
measure: Time of Maximum Plasma Morphine Concentration
timeFrame: 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
measure: Area Under the Curve to the Last Measurable Time Point for Plasma Morphine
timeFrame: 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
measure: Area Under the Curve to Infinity for Plasma Morphine
timeFrame: 0 (predose), and 2,4,6,6.5,7,7.5,8,8.5,9,9.5,10,12,18,24,36,48 hrs
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: CEDRA Clinical Research, LLC
state: Texas
Study officials:
affiliation: CEDRA Clinical Research, LLC
name: James P. Doherty, DO
role: PRINCIPAL_INVESTIGATOR
References: