clinical trial · NCT00829530
Ramipril 10 mg Capsule in Healthy Subjects Under Fed Conditions
Teva Pharmaceuticals USA·phase1·completed·n = 40
HealthyRamipril 10 mg capsuleAltace® 10 mg capsule
brief summary
The objective of this study is to compare the rate and extent of absorption of Ramipril 10 mg capsule (test) versus Altace® (reference), administered as 1 x 10 mg capsule under fed conditions.
started
Aug 1, 2004
primary completion
Oct 1, 2004
completion
Oct 1, 2004
last updated
Aug 19, 2024
detailed description
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Outcome: Confidence interval fell within 80-125% therefore met the FDA Bioequivalence criteria; no drug related, serious, unexpected adverse events were reported during the study.
official title
Randomized, 2-Way Crossover, Bioequivalence Study of Ramipril 10 mg Capsule and Altace® Administered as 1 x 10 mg Capsule in Healthy Subjects Under Fed Conditions
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol