clinical trial · NCT00840632
Trandolapril 4 mg Tablet Under Fasting Conditions
Teva Pharmaceuticals USA·phase1·completed·n = 40
HealthyTrandolapril 4 mg TabletsMavik® 4 mg Tablets
brief summary
The objective of this study is to compare the rate and extent of absorption of trandolapril from a test formulation of Trandolapril 4 mg Tablets versus the reference Mavik® 4 mg Tablets under fasting conditions.
started
Oct 1, 2004
primary completion
Nov 1, 2004
completion
Nov 1, 2004
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 Trandolapril 4 mg Tablets Versus Mavik® 4 mg Tablets in Normal Healthy Non-Smoking Male and Female Subjects
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol