clinical trial · NCT00841542
Amlodipine 10 mg Tablets Under Fasting Conditions
Teva Pharmaceuticals USA·phase1·completed·n = 28
HealthyAmlodipine BesylateNorvasc®
brief summary
The objective of this study is to compare the rate and extent of absorption of amlodipine from a test formulation of Amlodipine Besylate Tablets, 10 mg versus the reference Norvasc® 10 mg Tablets under fasting conditions.
started
Apr 1, 2003
primary completion
May 1, 2003
completion
May 1, 2003
last updated
Aug 20, 2024
detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
official title
A Two-Way Crossover, Open-Label, Single-Dose, Fasting, Bioequivalence Study of Amlodipine 10 mg Tablets Versus Norvasc® 10 mg Tablets in Normal Healthy Non-Smoking Male and Female Subjects
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol