Find Clinical Trials
Bioequivalence study of Fixed Dose Combination Gliclazide 60 mg + Metformin 1000 mg extended release tablet under fasting conditions
Servier Protocol Code:
S005189-201
Find a recruiting site
Name:
Institut de Recherches Internationales Servier, Département des études cliniques
Phone number:
+33 1 55 72 60 00
Official title: An Open-label, Balanced, Single-dose, Randomized, Two Treatment, Two Period, Two Sequence, Crossover Bioequivalence Study of Fixed Dose Combination Gliclazide 60 mg + Metformin 1000 mg Extended-release Tablet Compared to the Co-administration of Individual Tablets Diamicron® MR 60 mg and Glucophage® SR 1000 mg in Normal, Healthy, Adult Human Participants Under Fasting Condition
Interventions / Treatments
The treatment(s) given to the participants in the study.
- DIAMICRON®
- Glucophage®
Other study id numbers
Other identification numbers the study may be known by.
- S005189-201
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 45 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.