At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 14 enrolled
Drug / intervention
Amlodipine - reference +1 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.
Phase 1, Open-Label, Randomized, Single-Dose, 2-Treatment, 2-Period Crossover Bioavailability Study Comparing 10 Mg Amlodipine Besylate Orally Disintegrating Tablets, Manufactured By Aurobindo Pharma Ltd., India To 10 Mg Amlodipine Besylate Capsules, Manufactured By Pfizer France Under Fasted Conditions
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Aug 6, 2010·Updated Jan 28, 2021
In Brief
A Phase 1 clinical trial evaluating Amlodipine - reference and Amlodipine ODT - test for Healthy Volunteers. Completed, enrolled 14 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 capsule.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Volunteers
CountriesIndia
CollaboratorsAurobindo Pharma Ltd, Trident Life Sciences Ltd.
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2010
Primary CompletionJun 2010
First PostedAug 2010
TodayJul 2026
First PostedAug 6, 2010
Enrollment StartMar 1, 2010
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 15.9 years ago
Interventions
Amlodipine - referencedrug
Amlodipine capsule, 10 mg, single dose, with water
Amlodipine ODT - testdrug
Amlodipine orally disintegrating tablet (ODT), 10 mg, single dose, without water