In short
Clinical trials investigating Atorvastatin Calcium in this dataset are bioequivalence studies of two ezetimibe/atorvastatin tablet formulations. They look at whether the test product performs like the reference product in healthy volunteers. The main goals are to measure exposure in the body and show bioequivalence.
Key points
- Clinical trials of Atorvastatin Calcium in this dataset are Phase 1 bioequivalence studies. They compare two oral ezetimibe/atorvastatin tablet formulations in healthy volunteers. Both trials are completed and focus on whether the test product matches the reference product in body exposure. The main endpoints are Atorvastatin AUC0-t and Cmax, plus total ezetimibe AUC0-72 and Cmax. One trial enrolled 14 people and the other enrolled 36 people. These studies are about formulation comparison, not disease treatment.
Trial overview
Two clinical trials in this dataset studied Atorvastatin Calcium as part of an oral fixed-dose combination with ezetimibe. Both trials were designed to compare a test formulation, Ezetimiba/Atorvastatina Normogen 10 mg/80 mg comprimidos, with the commercial reference product, ATOZET 10 mg/80 mg comprimidos recubiertos con película.
Both studies were bioequivalence trials, which means they checked whether the two products gave similar drug exposure in the body.
Who participated
The trials enrolled healthy volunteers, not patients with a specific disease. One study enrolled 14 people, and the other enrolled 36 people.
This type of population is often used in early studies when the goal is to compare two formulations in a controlled way rather than to test treatment for a medical condition.
What was measured
The main endpoints were Atorvastatin AUC0-t and Atorvastatin Cmax, along with total ezetimibe AUC0-72 and total ezetimibe Cmax.
AUC0-t is a measure of total drug exposure from the start of dosing to the last time point measured, and Cmax is the highest blood level reached after taking the product.
These endpoints help researchers see whether the test product and the reference product behave similarly in the body.
Trial design and phase
Both studies were Phase 1 and interventional, meaning the researchers gave the study products and then measured the results.
Both trials were completed, so the planned testing was finished.
The brief study goal in both trials was to evaluate the relative bioavailability of the test formulation compared with the commercial reference and to demonstrate bioequivalence according to health authority criteria.
What the results mean for patients
These studies do not test whether Atorvastatin Calcium treats a disease in this dataset. Instead, they focus on whether two tablet products containing Atorvastatin Calcium and ezetimibe are similar enough to be considered interchangeable for study purposes.
Because the trials were done in healthy volunteers, the findings are mainly about product comparison, not about outcomes in people with high cholesterol or other patient groups.