NCT01004614

Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet

An Open, Randomized, Parallel-Cohort, 2-Periods, Crossover, Single Dose Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet In Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is being conducted to determine if 5 mg amlodipine 3rd Orally-Disintegrating (OD) tablet (new formulation) and 5 mg amlodipine 2nd OD tablet (commercial formulation) are bioequivalent.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Amlodipine	3rd OD 5 mg tablet single oral dose administered with water
DRUG	Amlodipine	2nd OD 5 mg tablet single oral dose administered with water
DRUG	Amlodipine	3rd OD 5 mg tablet single oral dose administered without water
DRUG	Amlodipine	2nd OD 5 mg tablet single oral dose administered without water

Timeline

• Start date: 2009-11-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2009-10-30
• Last updated: 2021-01-28
• Results posted: 2012-01-04

Locations

1 site across 1 country: Japan