Not applicable (submitted trial is a bioequivalence study in healthy subjects) research hub
3 indexed studies · 0 currently recruiting
- ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence Study
An open label, randomized, three-period, three-sequence, crossover bioavailability study to assess the pharmacokinetic and safety profile of Valacyclovir Oral Suspension compared to Valtrex® extemporaneous suspension in normal, healthy subjects under fasting conditions and to investigate the effect of food on the bioavailability of Valacyclovir Oral Suspension.
This study is testing a new liquid version of the medicine valacyclovir. It's comparing how well the new liquid is absorbed by the body compared to the usual liquid form. It will also check if food affects how the new liquid medicine works.
Czechia - ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence Study
Single dose, open-label, laboratory blinded, randomised, 2-treatment, 2-period, 2-sequence, crossover bioequivalence study of test product Perampanel 12 mg film-coated tablets versus reference product Fycompa 12 mg film-coated tablets (Eisai GmbH) in healthy adult male and female subjects under fasting conditions.
This study compares two versions of the same medicine, Perampanel, to make sure they work the same way in the body. It's a small study in healthy adults, helping ensure new generic medicines are just as effective as their original counterparts.
Czechia - ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence Study
Randomized, Open-label, Single-Dose, Two-treatment, Two-period, Cross-over, Pivotal Bioequivalence Study Comparing Amoxicilin/Clavulanic acid powder for oral suspension 600 mg/42.9 mg/5 mL to Augmentin ES 600 mg/42.9 mg/5 mL powder for oral suspension in Healthy Adult Male and Female Volunteers under Fed Conditions.
This study compares a new liquid antibiotic to a well-known one. We want to see if the body handles both medicines in the exact same way when taken by healthy adults after eating. It helps make sure new versions of medicines work just as well.
Czechia