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

NCT ID: NCT00853554

Last Updated: 2016-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-12-31
• Study Completion Date: 2002-12-31

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

A

Hydromorphone Hydrochloride tablet 8 mg

Group Type: EXPERIMENTAL

Hydromorphone Hydrochloride tablet 8 mg

Intervention Type: DRUG

Hydromorphone Hydrochloride tablet 8 mg, single dose fasting

B

Dilaudid® tablet 8 mg

Group Type: ACTIVE_COMPARATOR

Dilaudid® tablet 8 mg

Intervention Type: DRUG

Dilaudid® tablet 8 mg, single dose fasting

Interventions

Hydromorphone Hydrochloride tablet 8 mg

Hydromorphone Hydrochloride tablet 8 mg, single dose fasting

Intervention Type: DRUG

Dilaudid® tablet 8 mg

Dilaudid® tablet 8 mg, single dose fasting

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mallinckrodt

INDUSTRY

Sponsor Role: lead

Responsible Party

Mallinckrodt

Principal Investigators

Herbert Neuman, MD

Role: STUDY_DIRECTOR

Mallinckrodt

Locations

Gateway Medical Research

Saint Charles, Missouri, United States

Countries

United States

Other Identifiers

3249-02-769

Identifier Type: -

Identifier Source: org_study_id