At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 48 enrolled
Drug / intervention
Amlodipine +3 moredrug
Likely dose
Amlodipine 5 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.
An Open, Randomized, Parallel-Cohort, 2-Periods, Crossover, Single Dose Bioequivalence Study For 5 Mg Amlodipine Orally-Disintegrating Tablet In Healthy Male Subjects
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.·interventional·Posted Oct 30, 2009·Updated Jan 28, 2021
In Brief
A Phase 1 clinical trial evaluating Amlodipine for Healthy. Completed, enrolled 48 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesJapan
Collaborators--
Timeline
Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2009
Enrollment StartNov 2009
Primary CompletionDec 2009
TodayJul 2026
First PostedOct 30, 2009
Enrollment StartNov 1, 2009
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 16.7 years ago
Interventions
Amlodipinedrug
3rd OD 5 mg tablet single oral dose administered with water
Amlodipinedrug
2nd OD 5 mg tablet single oral dose administered with water
Amlodipinedrug
3rd OD 5 mg tablet single oral dose administered without water
Amlodipinedrug
2nd OD 5 mg tablet single oral dose administered without water