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CompletedNCT00759915Updated Aug 17, 2010Results posted

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

A Phase 1 interventional study of morphine sulfate extended-release capsules and KADIAN (morphine sulfate extended-release) capsules in Healthy, sponsored by Actavis Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-08-17.

Sponsored by Actavis Inc. (part of Teva Pharmaceutical Industries, Ltd.) · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy

Keywords

  • 10 mg
  • KADIAN capsules
  • 20 mg
  • fed conditions
  • bioequivalence
03

In context

Lead sponsor

Actavis Inc. is the lead sponsor of 95 studies on the registry; none are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.

First submitted before Actavis Inc. became part of Teva Pharmaceutical Industries, Ltd..

Browse Actavis Inc. studies →All Teva Pharmaceutical Industries, Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Other
    1

    Treatment A (test product) followed by Treatment B (reference product)

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

  • Other
    2

    Treatment B (reference product) followed by Treatment A (test product)

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

Interventions

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

07

Results

Posted Sep 1, 2009

Participant flow

Participant flow — Overall Study
MilestonePeriod 1: Treatment Aor BPeriod 2: Treatment A or B
Started1818
Completed1717
Not completed11
Withdrew: Withdrawal by subject10
Withdrew: Adverse event01

Outcome measures

PrimaryMaximum 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
Reported as:
Mean · ng/mL
Maximum Plasma Morphine Concentration
ng/mLKADIAN (2 x 10mg) CapsulesKADIAN 20mg Capsules
Maximum Plasma Morphine Concentration4.60 ± 1.824.29 ± 2.13
Statistical analysis
  • KADIAN (2 x 10mg) Capsules vs KADIAN 20mg Capsules · ANOVA · Mean ratio: 109.98 · 90% CI 100.1 to 120.8log-transformation
SecondaryTime 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
Reported as:
Median · Hr
Time of Maximum Plasma Morphine Concentration
HrKADIAN (2 x 10mg) CapsulesKADIAN 20mg Capsules
Time of Maximum Plasma Morphine Concentration12.00 ± 3.8312.00 ± 5.17
SecondaryArea 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
Reported as:
Mean · hr*ng/mL
Area Under the Curve to the Last Measurable Time Point for Plasma Morphine
hr*ng/mLKADIAN (2 x 10mg) CapsulesKADIAN 20mg Capsules
Area Under the Curve to the Last Measurable Time Point for Plasma Morphine76.44 ± 16.1276.33 ± 19.24
Statistical analysis
  • KADIAN (2 x 10mg) Capsules vs KADIAN 20mg Capsules · ANOVA · Mean ratio: 100.91 · 90% CI 96.96 to 105.0log-transformation
SecondaryArea 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
Reported as:
Mean · hr*ng/mL
Area Under the Curve to Infinity for Plasma Morphine
hr*ng/mLKADIAN (2 x 10mg) CapsulesKADIAN 20mg Capsules
Area Under the Curve to Infinity for Plasma Morphine90.09 ± 16.1892.43 ± 23.46
Statistical analysis
  • KADIAN (2 x 10mg) Capsules vs KADIAN 20mg Capsules · ANOVA · Mean ratio: 96.5 · 90% CI 92.3 to 100.97log-transformation

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm 1: Treatment A Followed by Treatment B———
Arm 2: Treatment B Followed by Treatment A———
Most frequent other events
Showing 10 of 14
Most frequent other events
EventArm 1: Treatment A Followed by Treatment BArm 2: Treatment B Followed by Treatment A
DizzinessNervous system disorders2/180/18
HeadacheNervous system disorders1/181/18
Alanine Aminotransferase IncreasedInvestigations1/180/18
HyperglycemiaMetabolism and nutrition disorders1/180/18
Dry MouthGastrointestinal disorders1/180/18
Pain in ArmMusculoskeletal and connective tissue disorders0/181/18
NauseaGastrointestinal disorders0/181/18
Perirectal AbscessInfections and infestations0/181/18
Nasal CongestionRespiratory, thoracic and mediastinal disorders0/181/18
PainGeneral disorders0/181/18

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Period 1: Treatment Aor BPeriod 2: Treatment A or BTotal
<=18 years000
Between 18 and 65 years181836
>=65 years000
Age Continuous
Age Continuous(years)Period 1: Treatment Aor BPeriod 2: Treatment A or BTotal
Mean36 ± 1229 ± 1033 ± 12
Sex: Female, Male
Sex: Female, Male(Participants)Period 1: Treatment Aor BPeriod 2: Treatment A or BTotal
Female7512
Male111324
Region of Enrollment
Region of Enrollment(participants)Period 1: Treatment Aor BPeriod 2: Treatment A or BTotal
United States181836
08

Study locations

1 site
  • CEDRA Clinical Research, LLC
    San Antonio, Texas 78217, United States
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2006, a primary completion of Sep 2006 and a completion of Oct 2006. It does not say whether these dates are actual or estimated.

Results were first posted in Sep 2009, 3 years after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 24, 2008
First posted
Sep 25, 2008
Start
Aug 2006
Primary completionActual
Sep 2006
CompletionActual
Oct 2006
Results first posted
Sep 1, 2009
Last update
Aug 17, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00759915
Lead sponsor
Actavis Inc.
First posted
Sep 25, 2008
Start date
Aug 2006
Primary completion
Sep 2006
Completion
Oct 2006
Results posted
Sep 1, 2009
Last update
Aug 17, 2010

Study contacts

James P. Doherty, DO
principal investigator · CEDRA Clinical Research, LLC
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2010. You cannot join it, but the record below documents what was studied.

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