Pharmacokinetic Comparisons of Two Donepezil Formulations

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

To compare the relative bioavailability and pharmacokinetic characteristics of a newly developed donepezil formulation with a conventional formulation in healthy subjects with a single dose, randomized, open-label, 2-sequence -2period crossover study.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Korea University Anam Hospital
• Collaborator: Chong Kun Dang Pharmaceutical Corp.
• Treatments: Donepezil

Criteria

Inclusion Criteria:

• Males age 20 to 45 years

• Body weight > 45 kg with +/- 20% of ideal body weight

• Signed and dated informed consent form which meets all criteria of current FDA and KFDA regulations

Exclusion Criteria:

• subjects with acute conditions.

• presence of history affecting ADME

• Clinically significant history or current evidence of a hepatic, renal, gastrointestinal, or hematologic abnormality

• Hepatitis B, hepatitis C, or HIV infection revealed on the laboratory findings

• Any other acute or chronic disease

• A history of hypersensitivity to donepezil

• A history of alcohol or drug abuse

• Participation in another clinical trial within 3 months

• smoked >10 cigarettes daily

• consumption over 5 glasses daily of beverages containing xanthine derivatives

• use of any medication having the potential to affect the study results within 10 days before the start of the study.