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Comparison of KADIAN 100 mg When Dosed With Alcohol Under Fasting and Fed Conditions Compared to Water

NCT00768183 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2020-07-16

No results posted yet for this study

Summary

The objective of this study was to compare the single-dose relative bioavailability of Alpharma Branded Products Division Inc. (KADIAN) 100 mg morphine sulfate extended-release capsules when dosed with alcohol under fasting and fed conditions compared to water.

Conditions

  • Healthy

Interventions

DRUG

KADIAN Capsule + alcohol (under fasting conditions)

Capsules 100 mg + 240 mL 40% ethanol in 4 shots of 60 mL

DRUG

KADIAN Capsule + water (under fasting conditions)

Capsules 100mg + 240 mL in 4 shots of 60 mL

DRUG

morphine sulfate IR oral solution + water

Morphine sulfate IR oral solution + water (under fasting conditions)

DRUG

KADIAN Capsule + alcohol (under fed conditions)

Capsules 100 mg + 240 mL 40% ethanol in 4 shots of 60 mL

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • James C Kisicki, MD · MDS Pharma Services

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2006-07-31
Completion
2006-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00768183 on ClinicalTrials.gov