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Multiple-Dose Study on the Bioequivalence of One Tablet of Gliclazide MR 120 mg (S005190) and Two Tablets of Gliclazide MR 60 mg (Diaprel® MR) in Healthy Participants under Fed Conditions.
Servier Protocol Code:
S005190-206
EU Trial (CTIS) Number:
2024-519640-32-00
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Name:
Institut de Recherches Internationales Servier, Département des études cliniques
Phone number:
+33 1 55 72 60 00
Official title: A Multiple-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 (Diaprel® MR) in Healthy Participants under Fed Conditions.
Other study id numbers
Other identification numbers the study may be known by.
- S005190-206
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.