A Study to Assess the Food Effect on Bioavailability of Metformin/Gliclazide in Healthy Participants
Summary
This study will assess the food effect on bioavailability of Metformin/Gliclazide fixed dose combination tablet in fed and fasted state.
Timeline
- Start
- 2018-03-06
- Primary completion
- 2018-04-22
- Completion
- 2018-04-22
Outcome
Mixed primary results
registry analysis (equivalence test); Metformin-Gliclazide (Fasted) vs Metformin-Gliclazide (Fed); Ratio of mean values 175.6652 (90% CI 153.7790 to 200.6664) NCT03467971 ↗
registry analysis (equivalence test); Metformin-Gliclazide (Fasted) vs Metformin-Gliclazide (Fed); Ratio of mean values 104.457 (90% CI 97.7660 to 111.6060) NCT03467971 ↗
registry analysis (equivalence test); Metformin-Gliclazide (Fasted) vs Metformin-Gliclazide (Fed); Ratio of mean values 180.7734 (90% CI 157.0135 to 208.1287) NCT03467971 ↗
registry analysis (equivalence test); Metformin-Gliclazide (Fasted) vs Metformin-Gliclazide (Fed); Ratio of mean values 105.0818 (90% CI 98.0047 to 112.6699) NCT03467971 ↗
registry analysis (equivalence test); Metformin-Gliclazide (Fasted) vs Metformin-Gliclazide (Fed); Ratio of mean values 127.7779 (90% CI 110.2732 to 148.0612) NCT03467971 ↗
registry analysis (equivalence test); Metformin-Gliclazide (Fasted) vs Metformin-Gliclazide (Fed); Ratio of mean values 105.4183 (90% CI 94.5723 to 117.5081) NCT03467971 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gliclazide | Small molecule | 30 mg | Oral |
| Subject | Metformin | Small molecule | 1000 mg | Oral |
Indications
No indication recorded.