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Bioequivalence of One Tablet of Gliclazide MR 120 mg (S005190) and Two Tablets of Gliclazide MR 60 mg (Diamicron® MR) in Healthy Participants under Fasting Conditions
Servier Protocol Code:
S005190-203
Find a recruiting site
Name:
Institut de Recherches Internationales Servier, Département des études cliniques
Phone number:
+33 1 55 72 60 00
Official title: A Single-Dose, Randomized, Open-Label, Two-Treatment, Two-Sequence, Two-Period, Crossover Bioequivalence Study of One Tablet of Gliclazide MR 120 mg
(S005190) and Two Tablets of Gliclazide MR 60 mg (Diamicron®MR) in Healthy Participants under Fasting Conditions.
Other study id numbers
Other identification numbers the study may be known by.
- S005190-203
Eligibility Criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligible age for the study
18 years to 50 years
(Adult)
Sex
Male/FemaleAccepts Healthy Volunteers
YesHow is the study designed?
Allocation
How participants are assigned to different groups. Allocation can be random (randomized) or predetermined (non-randomized). Randomized means that participants are assigned at random to their participant group / arm.
Interventional study model
How treatments are given and tested in a study.
Crossover
A crossover study design involves participants receiving multiple treatments one after the other, with a break in between. Each participant receives all treatments and acts as their own control, meaning their responses to different treatments are compared directly within the same individual, rather than between different people. This helps researchers see the true effect of each treatment more clearly.