None listed
Conditions
Interventions
Intervention1: Gliclid 60 mg MR tablet (Gliclazide 60 mg MR tablet)
Name of the drug: Gliclazide: bioequivalence study,
dose: 60 mg,
frequency: single dose,
route of administration: oral,
duration of
Sponsors
The ACME Laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Able to comprehend the nature and purpose of the study and willing to give written informed consent for participation in the study 2 Willing to be available for the entire study period and to comply with protocol requirements. 3 Normal, healthy, adult, human subject of 18-45 years (both inclusive) of age. 4 Body mass index in the range of 18 â?? 30 kg/m2 (both inclusive).
Exclusion criteria
Exclusion criteria: • Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or bloodâ??forming organs. • History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past. • History of severe infection or major surgery in the past 6 months. • History of Minor surgery or fracture within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax, AUC0-t and AUC0-â??Timepoint: Day 01- Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax , AUC_%Extrap_obs, λz and t1/2Timepoint: Day 01- Day 14 | — |
Countries
India
Contacts
Public ContactDr Harish S
ICBio Clinical Research Pvt Ltd
Outcome results
None listed