CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 18 enrolled
Drug / intervention
Amlodipine - reference +2 moredrug
Likely dose
Amlodipine - reference 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01138826
NCT01138826Phase 1Completed
CompareCT.gov

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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Jun 7, 2010·Updated Jan 28, 2021

In Brief

A Phase 1 clinical trial evaluating Amlodipine - reference and Amlodipine ODT - test for Healthy Volunteers. Completed, enrolled 18 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesIndia
CollaboratorsAurobindo Pharma Ltd, Trident Life Sciences Ltd.

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 7, 2010
Enrollment StartMay 1, 2010
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 16.1 years ago

Interventions

Amlodipine - referencedrug

10 mg tablet, single dose, with water

Amlodipine ODT - testdrug

10 mg orally disintegrating tablet (ODT), single dose, with water

Amlodipine ODT - testdrug

10 mg orally disintegrating tablet (ODT), single dose, without water