Overview

Bioequivalence Study of Morphine Sulfate 60 mg Extended-Release Tablets Under Fed Conditions

Status:
Completed
Trial end date:
2006-12-01
Target enrollment:
0
Participant gender:
All
Summary
The study was to evaluate the relative bioavailability of morphine and morphine-6-glucuronide from 2 tablet products and determine if the 2 products were bioequivalent to each other.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Ranbaxy Inc.
Treatments:
Morphine
Criteria
Inclusion Criteria:

For inclusion into the trial, subjects were required to fulfill all of the following
criteria:

1. Healthy subjects at least 18 years of age.

2. Willingness to provide written informed consent after being informed of the nature of
the study.

3. Body mass index (BMI) between 18 and 30 and a weight of at least 110 pounds.

4. Good health as determined by a lack of clinically significant abnormalities in health
assessments performed at Screening, as judged by the physician.

Exclusion Criteria:

ny of the following was regarding as a criterion for excluding subjects from the trial:

1. Hypersensitivity to morphine sulfate (MS Contin®), naltrexone (ReVia®), or related
compounds.

2. Conditions that affected the absorption, metabolism, or passage of drugs out of the
body (eg, sprue, celiac disease, Crohn's disease, colitis, liver, kidney, or thyroid
conditions).

3. Recent history (within 1 year) of mental illness, drug addiction, drug abuse, or
alcoholism.

4. A hematocrit value of ≤ 33.0% for females and ≤ 37.0% for males.

5. Donation of > 500 mL of blood in the past 8 weeks prior to study drug dosing or
difficulty in donating blood.

6. Receipt of an investigational drug within the 4 weeks prior to study drug dosing.

7. Current use of any systemic prescription medications, except for
oral/cutaneous/vaginal/injectable hormone contraceptives, within the 7 days prior to
study drug dosing or over-the-counter (OTC) medication within 3 days of study drug
dosing.

This prohibition did not include vitamins or herbal preparations taken as nutritional
supplements for non-therapeutic indications, as judged by the attending physician.

Any nonprescription medication consumption reported was to be reviewed by the
investigator prior to dosing. At the discretion of the investigator, these volunteers
could be enrolled if the medication was not anticipated to alter study integrity or
the safety of the subject.

8. Regular smoking of more than 5 cigarettes weekly or the regular daily use of nicotine
containing products beginning 3 months before study drug administration through the
final evaluation.

Subjects had to be able to refrain from smoking while confined in the clinic.

9. Female subjects who were lactating or had a positive pregnancy test at Screening and
prior to each of the treatment periods.

Females were to use a medically acceptable method of contraception throughout the
entire study period and for 1 week after study completion. Medically acceptable
methods of contraception that could have been used by the subject and/or her partner
were oral contraceptives/patches, progestin injection or implants, condom with
spermicide, diaphragm with spermicide, intrauterine device (IUD), vaginal spermicidal
or hormonal suppository, surgical sterilization of themselves or their partner(s), or
abstinence. Females using contraceptive medications/devices must have used them
consistently for at least 3 months prior to receiving study drug.

10. Alcohol, grapefruit beverages or foods, caffeine, or xanthine beverages or foods
beginning 48 hours before each study drug administration through the last
pharmacokinetic (PK) sample of each treatment period.

Such restricted items included coffee, tea, iced tea, Coke®, Pepsi®, Mountain Dew®,
chocolate, brownies, etc.

11. Regular use of any drugs known to induce or inhibit hepatic drug metabolism (examples
include barbiturates, carbamazepine, rifampin, phenylhydantoins, phenothiazines,
cimetidine, omeprazole, macrolides, imidazoles, fluoroquinolones) within 30 days prior
to study drug administration.

12. Positive test results for human immunodeficiency virus (HIV), hepatitis B surface
antigen (HBsAg), and hepatitis C antibody at Screening.

13. Positive test results for drugs of abuse or pregnancy at Screening and prior to each
study drug dosing period.

14. Subjects having emesis after either dose of naltrexone administered prior to the study
drug were not to be continued in the study.