#1 Clinical Trials Search in Europe

Atorvastatin Calcium

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.

Table of Contents

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.[1][2]

Both studies were bioequivalence trials, which means they checked whether the two products gave similar drug exposure in the body.[1][2]

Who participated

The trials enrolled healthy volunteers, not patients with a specific disease.[1][2] One study enrolled 14 people, and the other enrolled 36 people.[1][2]

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.[1][2]

What was measured

The main endpoints were Atorvastatin AUC0-t and Atorvastatin Cmax, along with total ezetimibe AUC0-72 and total ezetimibe Cmax.[1][2]

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.[1][2]

These endpoints help researchers see whether the test product and the reference product behave similarly in the body.[1][2]

Trial design and phase

Both studies were Phase 1 and interventional, meaning the researchers gave the study products and then measured the results.[1][2]

Both trials were completed, so the planned testing was finished.[1][2]

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.[1][2]

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.[1][2]

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.[1][2]

Trial ID Phase Condition studied Status Enrollment
2023-504987-40-00 Phase 1 Healthy volunteers Completed 14
2023-506559-10-00 Phase 1 Healthy volunteers Completed 36

FAQ

  • What are the clinical trials of Atorvastatin Calcium studying? They are studying bioequivalence between two oral ezetimibe/atorvastatin tablet formulations. The trials compare how much Atorvastatin and ezetimibe enter the body.
  • Who can take part in these trials? The trials enrolled healthy volunteers. This means the studies were not in patients with a disease, but in people without known illness for the purpose of comparing the two products.
  • What phase are these trials? Both trials are Phase 1 studies. Phase 1 trials are early studies that often focus on how the body handles a medicine and whether two products act the same in the body.
  • What conditions are being studied? The condition listed is healthy volunteers, which is the study population. The trials are not testing treatment for a disease; they are testing formulation similarity.
  • What do the trials measure? The main measurements are Atorvastatin AUC0-t and Cmax, plus total ezetimibe AUC0-72 and Cmax. These are blood exposure measures that help show how much of the drug reaches the body and how fast it appears.

Ongoing Clinical Trials on Atorvastatin Calcium

  • Study comparing two forms of ezetimibe and atorvastatin tablets in healthy volunteers to check if they work the same way in the body

    Not recruiting

    1 1 1
    Investigated drugs:
    Spain

Glossary

  • Bioequivalence: A comparison showing that two medicine products give similar drug exposure in the body. If they are bioequivalent, they are expected to act in a similar way.
  • Relative bioavailability: A measure of how much and how fast a test product enters the body compared with a reference product.
  • Reference product: The standard product used for comparison in a study. In these trials, the commercial product was used as the reference.
  • Test formulation: The product being studied to see if it matches the reference product.
  • Healthy volunteers: People without the disease being studied who join a trial to help compare products or study basic body handling of a medicine.
  • Phase 1: An early stage of clinical research. It usually focuses on basic safety, body exposure, and comparison of products.
  • AUC0-t: A blood measurement called area under the curve from time zero to the last measured time. It shows total drug exposure over time.
  • Cmax: The highest level of a drug found in the blood after it is taken.
  • Interventional study: A trial where researchers give a treatment or product and then measure what happens.
  • Enrollment: The number of people who took part in a trial.

References

  1. https://clinicaltrials.gov/study/2023-504987-40-00
  2. https://clinicaltrials.gov/study/2023-506559-10-00