NCT00645554

A Single Dose, Cross-over Bioequivence Study Comparing Galantamine IR (Immediate Release) Table and Galantmine OS (Oral Solution) in Healthy Volunteers

A Bioequivalent Study to Compare Galantamine Oral Solution With Marketed Galantamine Capsule After Single Oral Administration of 10 mg.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Xian-Janssen Pharmaceutical Ltd. · Industry
• Sex: Male
• Age: 18 Years – 48 Years
• Healthy volunteers: Accepted

Summary

The purpose of this open-label, single dose, two-treatment, two-period, cross-over study is to evaluate the pharmacokinetic profile and tolerability of galantamine oral solution and galantamine tablet.

Detailed description

This is an open-label, single dose, two-treatment, two-period, cross-over study to evaluate the pharmacokinetic profile and tolerability of galantamine oral solution and galantamine tablet. All patients are healthy male patients who are 18-45 years old with BWI (Body Weight Index) between 18-28 kg/m2. All patients must sign informed consent before being enrolled. 24 patients were randomized in the study. The duration of study is 9 days. All patients must stay at site unit for 12 hours after single oral administration otherwise patients could stay home but must return to site at specific date and time. The day before dosing day (baseline), patients were randomized to one of the two groups to be administered either 4mg galantamine oral solution (1ml) or galantamine tablet (1 tablet). After 7-day washout period, patients were crossed over to receive the other formulation. Pharmacokinetic observation will last to 32 hours after dosing. Plasma were collected at immediately before dosing and 0.25, 0.5, 0.75, 1.5, 2, 3, 4, 6, 8, 12, 24 and 32 hours after dosing to determine plasma concentration of galantamine. Safety and tolerance evaluation will last until Day 9. Safety evaluation include adverse events, vital signs, physical examination, electrocardiogram and laboratory tests. On study Day 1, patients will take either 4mg galantamine oral solution (1ml) or 4mg galantamine tablet (1 tablet). After 7-day washout period, on Day 8, patients will cross over to take the other formulation, the dosage and administration are the same.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Galantamine oral solution

Timeline

• Completion: 2004-09-01
• First posted: 2008-03-27
• Last updated: 2011-05-19