NCT01138826

Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablet (ODT) And 10 Mg Amlodipine Besylate Tablets

Phase 1, Open-Label, Randomized, Single-Dose, 3-Treatment, 6-Sequence, 3-Period Crossover Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablets, Manufactured By Aurobindo Pharma Ltd., India To Amlodipine Besylate 10 Mg Tablets Manufactured by Pfizer Illertissen, Germany Under Fasted Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is being performed to determine the bioavailability, or extent of absorption into the body, of a 10 mg amlodipine besylate orally disintegrating tablet (ODT) as compared to the bioavailability of a 10 mg amlodipine besylate (non-ODT) tablet.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Amlodipine - reference	10 mg tablet, single dose, with water
DRUG	Amlodipine ODT - test	10 mg orally disintegrating tablet (ODT), single dose, with water
DRUG	Amlodipine ODT - test	10 mg orally disintegrating tablet (ODT), single dose, without water

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2010-06-07
• Last updated: 2021-01-28
• Results posted: 2011-07-20

Locations

1 site across 1 country: India