NCT00768183

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

Phase 1, Single-Center, Open-label, Drug Interaction Study to Evaluate the Effect of Alcohol on the PK of Morphine Sulfate ER (KADIAN) Capsules in Healthy Adults Under Fasting and Fed Conditions and Relative BA to Morphine Solution

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: Male
• Age: 21 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

This study was to evaluate the effect of consumming alcohol on the pharmacokie and bioavailability of Alpharma Branded Products Division Inc. (KADIAN) 100 mg morphine sulfate extended-release capsules under fasting and fed conditions. In addition, the pharmacokinetics of an immediate release solution following a 20 mg dose was assessed for informational purposes and for possible modeling.

Conditions

• Healthy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-05-01
• Primary completion: 2006-07-01
• Completion: 2006-07-01
• First posted: 2008-10-07
• Last updated: 2020-07-16

Locations

1 site across 1 country: United States