At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 44 enrolled
Drug / intervention
Test GIR +1 moredrug
Likely dose
Test GIR 500 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Open-label, 2-Way-Crossover Study Assessing the Bioequivalence Between Single Doses of 500 mg Glucophage Immediate Release (GIR) Tablets (Sino-American Shanghai Squibb Pharmaceuticals Ltd./ Manufactured in China) and 500 mg GIR Tablets (Merck Santé s.a.s. in Semoy/ Manufactured in France) Under Fed and Fasted State in Two Groups of Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating Test GIR and Reference GIR for Healthy. Completed, enrolled 44 participants across 1 site.
Detailed Summary
The study will assess the bioequivalence between single doses of glucophage immediate release (GIR) test tablets and GIR reference tablets under fed and fasted state in healthy subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesChina
Collaborators--
Timeline
Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedJan 2018
Enrollment StartJan 2018
Primary CompletionJan 2018
TodayJul 2026
First PostedJan 8, 2018
Enrollment StartJan 10, 2018
Primary CompletionJan 29, 2018
TodayJul 2, 2026
Enrollment to primary: 19 daysPosted 8.5 years ago
Interventions
Test GIRdrug
Participants received 500 milligrams (mg) test GIR in fasting or fed state on either Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2).
Reference GIRdrug
Participants received 500 mg reference GIR in fasting or fed state on either Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2).