Bioequivalence Study of Amoxicillin/Clavulanic Acid Oral Suspension Compared with Reference Product in Healthy Adult Volunteers under Fed Conditions

1 1 1

What is this study about?

The trial examines a medication that combines two antibiotics, Amoxicillin/Clavulanic acid, provided as a powder that is mixed with water to create a liquid oral suspension. The same antibiotic combination is also available as a branded product called Augmentin ES, which is prepared in the same way. The study enrolls adult men and women who are healthy and do not have an infection.

The purpose is to assess whether the test product and the branded product are bioequivalence, meaning they provide the same amount of medicine to the body. Participants will take one of the liquid preparations after a regular meal, then, after a short interval, will take the other preparation after another meal. Blood samples will be collected to compare how the two products are absorbed, without further technical detail.

Who Can Join the Study?

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Quinta-Analytica s.r.o. Prague Czechia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
18.09.2023

Trial locations

Trial ID:
2023-503233-22-00
Protocol code:
01-AMO-CLA-BIO-22
Trial Phase:
Human Pharmacology (Phase I) – Bioequivalence Study

Other Trials to Consider

  • Study on High-Dose Short-Course Antibiotics for Critically Ill Patients with Pneumonia, Intra-Abdominal, or Bloodstream Infections: Ceftriaxone, Linezolid, and Cefotaxime

    Recruiting

    1 1 1 1
    Belgium The Netherlands
  • Study on the Effect of Amoxicillin in Preschool Children with Pneumonia

    Recruiting

    1 1 1
    Investigated drugs:
    Norway