Trials / Completed
CompletedNCT03583385
Glucophage® Extended Release (XR) 750 Milligram (mg) Indonesia Bioequivalence (BE) Study
A Randomized, Open-label, Two-way Crossover Study Assessing the Bioequivalence (BE) Between Single Dose of 750 mg Glucophage® XR Tablets (PT Merck Tbk, Jakarta, Indonesia-Manufactured) and 750 mg Glucophage® XR Tablets (Merck Santé, Semoy, France-Manufactured) Under Fasted State in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Merck KGaA, Darmstadt, Germany · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess bioequivalence between metformin hydrochloride (Glucophage® XR) manufactured in PT Merck Tbk, Indonesia (test drug) and metformin hydrochloride (Glucophage® XR) manufactured in Merck Santé, France (comparator drug) following single oral dose administration under fasting condition.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Glucophage XR (Test drug) | Participants received single oral dose of Glucophage® XR tablet manufactured by PT Merck Tbk, Jakarta, Indonesia (Test Drug) under fasted conditions. |
| DRUG | Glucophage XR (Comparator drug) | Participants received single oral dose of Glucophage® XR tablet manufactured by Merck Santé, Semoy, France (Comparator Drug) under fasted conditions. |
Timeline
- Start date
- 2018-08-16
- Primary completion
- 2018-10-05
- Completion
- 2018-10-05
- First posted
- 2018-07-11
- Last updated
- 2019-11-25
- Results posted
- 2019-11-25
Locations
1 site across 1 country: Indonesia
Source: ClinicalTrials.gov record NCT03583385. Inclusion in this directory is not an endorsement.