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Fasting Study of Hydromorphone Hydrochloride 8 mg Tablets and Dilaudid 8 mg Tablets

This study has been completed.
Sponsor:
Information provided by:
Mallinckrodt
ClinicalTrials.gov Identifier:
NCT00853554
First received: February 26, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted

February 26, 2009
February 26, 2009
December 2002
December 2002   (final data collection date for primary outcome measure)
Bioequivalence based on AUCt, AUCinf and Cmax [ Time Frame: Two-period crossover with blood samples obtained prior to and following each dose at selected times through 24 hours. Washout period between doses was 7 days. ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Fasting Study of Hydromorphone Hydrochloride 8 mg Tablets and Dilaudid 8 mg Tablets
An Open-Label, Randomized, Two-Period, Crossover Study to Evaluate the Relative Bioavailability of a Test Tablet Formulation of Hydromorphone Hydrochloride (8 mg) Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (DILAUDID®, 8 mg Tablet, Knoll Pharmaceutical Company) in Normal Human Subjects Under Fasting Conditions

The objective of this open-label, randomized, two-period crossover study was to compare the oral bioavailability of a Mallinckrodt test tablet formulation of hydromorphone 8 mg to an equivalent oral dose of a commercially available hydromorphone tablet (DILAUDID® 8 mg, Knoll Pharmaceutical Company) in a test group of healthy subjects under fasting conditions.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
  • Drug: Hydromorphone Hydrochloride tablet 8 mg
    Hydromorphone Hydrochloride tablet 8 mg, single dose fasting
  • Drug: Dilaudid® tablet 8 mg
    Dilaudid® tablet 8 mg, single dose fasting
  • Experimental: A
    Hydromorphone Hydrochloride tablet 8 mg
    Intervention: Drug: Hydromorphone Hydrochloride tablet 8 mg
  • Active Comparator: B
    Dilaudid® tablet 8 mg
    Intervention: Drug: Dilaudid® tablet 8 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
December 2002
December 2002   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Males or non-pregnant, non-lactating females, 18 years of age or older.
  2. Female subjects must be postmenopausal for at least one year, or surgically sterile, or practicing adequate non-hormonal contraception for at least 3 months prior to and for the duration of study participation. All female subjects will undergo a pregnancy test at screening and at check-in to the clinical study site for every dosing period. The results of the test must be negative for continued participation.
  3. Weight must be within 15% of the ideal weight for height and frame, as adopted by the Metropolitan Life Insurance Co., 1993.
  4. Qualifying subjects must be in good health and physical condition as determined by a screening medical history obtained within 30 days prior to study start. Subjects should not present with a history of significant past illness expected to affect the investigation.
  5. The normal status of subjects will be confirmed by the following procedures:

    1. Laboratory tests (serum chemistry, hematology, urinalysis)
    2. Human immunodeficiency virus (HIV), hepatitis, alcohol, and "drugs of abuse" testing will be done at screening. Results of the HIV, hepatitis, alcohol, and "drugs of abuse" tests must be negative or non-reactive for
    3. Electrocardiogram: A 12-lead electrocardiogram (ECG) will be obtained for all subjects. This ECG must be interpreted by appropriately trained and experienced medical personnel. A subject with an ECG that is not within normal range does not qualify, unless specifically accepted (with comment) by the investigator.
  6. Subjects must be able to provide written consent and agree to abide by the study requirements.

Exclusion Criteria:

  1. History of alcohol, drug, or narcotic abuse or dependence.
  2. Chronic use of tranquilizers, sedatives, aspirin, antibiotics, or other medications.
  3. History or presence of major organ dysfunction.
  4. History of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or neurological disorder capable of altering the absorption, metabolism, or elimination of drugs or constituting a risk factor when taking hydromorphone.
  5. History of anxiety, tension, severe agitation, psychosis, or mental depression.
  6. Family history or diagnosis of epilepsy or other seizure disorder.
  7. History of acute abdominal conditions.
  8. History of conditions that might contraindicate or require caution be used in the administration of hydromorphone including: renal impairment, hepatobiliary or pancreatic disease, GI obstruction, cardiac disease, obstructive pulmonary disease, acute or severe bronchial asthma, hypercarbia, elevated intracranial pressure, depleted blood volume, paralytic ileus, or allergy to hydromorphone, any opiate agonists, or naltrexone.
  9. Administration of any other investigational drug during the 30 days prior to enrollment into the study.
  10. Subjects who smoke or have a history of smoking, or use nicotine-containing products.
  11. Subjects who have donated blood within 30 days prior to study entry, including that withdrawn during the conduct of any other clinical study.
  12. Subjects presenting with acute illness.
  13. Subjects who have taken prescription drugs within 14 days or over-the-counter medications (including herbal preparations) within 7 days prior to dosing except for standard daily dose multivitamins.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00853554
3249-02-769
No
Herbert Neuman, MD/Chief Medical Officer, Mallinckrodt
Mallinckrodt
Not Provided
Study Director: Herbert Neuman, MD Mallinckrodt
Mallinckrodt
February 2009

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