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Glucophage® Extended Release (XR) 750 Milligram (mg) Indonesia Bioequivalence (BE) Study
Phase 1 trial testing Glucophage XR (Test drug) in Healthy in 48 participants. Completed in 5 October 2018.
| Lead sponsor | Merck KGaA, Darmstadt, Germany |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | other |
| Enrollment | 48 |
| Start date | 16 August 2018 |
| Primary completion | 5 October 2018 |
| Estimated completion | 5 October 2018 |
| Sites | 1 location across Indonesia |
Merck KGaA, Darmstadt, Germany — full company profile →
Adults 18 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The maximum plasma concentration of Metformin.
| Group | Value | 95% CI |
|---|---|---|
| Glucophage XR (Test) | 1109 | ± 318.4 |
| Glucophage XR (Comparator) | 1087 | ± 336.3 |
Area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration.
| Group | Value | 95% CI |
|---|---|---|
| Glucophage XR (Test) | 7387 | ± 2535.7 |
| Glucophage XR (Comparator) | 6977 | ± 2512.0 |
AUC (0-inf) is defined as the area under the plasma concentration versus time curve (AUC) from time zero (predose) to extrapolated infinite time (0-inf).
| Group | Value | 95% CI |
|---|---|---|
| Glucophage XR (Test) | 7678 | ± 2559.5 |
| Glucophage XR (Comparator) | 7250 | ± 2523.6 |
Time of the maximum drug concentration.
| Group | Value | 95% CI |
|---|---|---|
| Glucophage XR (Test) | 3.50 | 2.00 – 6.00 |
| Glucophage XR (Comparator) | 3.00 | 1.50 – 6.00 |
Elimination Half Life (t1/2) was defined as the time required for the concentration or amount of drug in the body to be reduced by one-half.
| Group | Value | 95% CI |
|---|---|---|
| Glucophage XR (Test) | 5.82 | ± 2.875 |
| Glucophage XR (Comparator) | 6.03 | ± 3.292 |
An adverse event (AE) was defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment. An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenit
| Group | Value | 95% CI |
|---|---|---|
| Glucophage XR (Test) | 5 | |
| Glucophage XR (Comparator) | 9 |
| Group | Value | 95% CI |
|---|---|---|
| Glucophage XR (Test) | 0 | |
| Glucophage XR (Comparator) | 0 |
Time frame: Up to Day 51. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Glucophage XR (Test) | Glucophage XR (Comparator) |
|---|---|---|---|
| Headache | Nervous system disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Stools loose | Gastrointestinal disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Dermatitis venenata | Skin and subcutaneous tissue disorders | — | — |
| Conjunctival hyperaemia | Eye disorders | — | — |
| Urinary tract bleed microscopic | Renal and urinary disorders | — | — |
| Hemoglobin decreased | Blood and lymphatic system disorders | — | — |
Data from ClinicalTrials.gov NCT03583385 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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