CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 68 enrolled
Drug / intervention
Amlodipine-benazepril 10 mg-20 mg capsules +1 moredrug
Likely dose
Amlodipine-benazepril 10 mg-20 mg or Lotrel® 10 mg-20 mg, 1 capsuleAI-extracted
Key inclusion· 4
  • ✓Male or non-child-bearing potential female (post-menopausal or surgically sterile)
  • ✓Age 18 years or older
  • ✓Non-smoker
  • ✓Capable of providing informed consent
Key exclusion· 25
  • ✕Clinically significant illness within 4 weeks prior to study medication administration
  • ✕Clinically significant surgery within 4 weeks prior to study medication administration
  • ✕Any abnormality on medical screening deemed clinically significant
  • ✕Positive testing for hepatitis B, hepatitis C, or HIV

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

Search/NCT00835367
NCT00835367Phase 1Completed
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Randomized, 2-way, Crossover, Bioequivalence Study of Amlodipine-Benazepril 10mg-20mg Capsules and Lotrel® Administered as 1 x 10 Mg-20 mg Capsule in Healthy Subjects Under Fed Conditions.

Teva Pharmaceuticals USA·interventional·Posted Feb 3, 2009·Updated Aug 21, 2024

In Brief

A Phase 1 clinical trial evaluating Amlodipine-benazepril 10 mg-20 mg capsules and Lotrel® 10 mg-20 mg capsule for Healthy. Completed, enrolled 68 participants across 2 sites.

Detailed Summary

The objective of this study is to compare the rate and extent of absorption if amlodipine-benzazepril 10 mg-20 mg capsules (test) versus Lotrel® (reference),administered as 1 x 10 mg- 20 mg capsule under fed conditions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesCanada
Collaborators--

Timeline

Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 3, 2009
Enrollment StartMar 1, 2004
Primary CompletionMar 1, 2004
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 17.4 years ago

Interventions

Amlodipine-benazepril 10 mg-20 mg capsulesdrug

1 x 10-20 mg

Lotrel® 10 mg-20 mg capsuledrug

1 x 10-20 mg