Phase 1
N=48
Glucophage® Extended Release (XR) 750 Milligram (mg) Indonesia Bioequivalence (BE) Study
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT03583385 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Maximum Observed Plasma Concentration (Cmax) of Metformin — 1109; 1087 Nano-gram per milliliter (ng/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Glucophage XR (Test drug) (Drug); Glucophage XR (Comparator drug) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Metformin |
1109; 1087 | — |
| PRIMARY Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Metformin |
7387; 6977 | — |
| SECONDARY Area Under Plasma Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Metformin |
7678; 7250 | — |
| SECONDARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of Metformin |
3.50; 3.00 | — |
| SECONDARY Terminal Elimination Half-life in Plasma (t½) of Metformin |
5.82; 6.03 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs |
5; 9; 0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Participants has provided written informed consent prior to the conduct of any study-related activities
- Body mass index of 18 to 25 kilogram per square meter (kg/m^2)
- Good physical and mental health status, determined on the basis of medical history and physical examination
- Vital signs (blood pressure, pulse rate, respiratory rate and body temperature) in sitting position within the normal range or showing no clinically relevant deviation per the Investigator's opinion
- All values for laboratory assessments (hematology, clinical chemistry and urinalysis) within the normal range or showing no clinically relevant deviation per the Investigator's opinion
- No clinically significant abnormality on 12-lead electrocardiogram (ECG) recording as judged by the Investigator; corrected QT interval (QTc) (Bazett) should be less than equals to ( =) 1.5 upper limit of normal (ULN)
- History or presence of renal failure or renal dysfunction based on clinical symptoms and finding (serum creatinine concentration >1.4 milligram per milliliter (mg/mL)
- Ascertained or presumptive hypersensitivity to the active drug substance and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study
- Receipt of any prescription or non-prescription medication within 14 days before the first drug administration, except for hormonal contraceptives in female, and including multivitamins and herbal products (e.g. St John's Wort)
- Consumption of large quantities of methylxanthine-containing beverages (> 5 cups of coffee/day or equivalent)
- Consumption of grapefruit, orange, cranberry or juices of these three fruits, 24 hours prior to drug administration
- Known lack of participant compliance or inability to communicate or cooperate with the Investigator (e.g., language problem, poor mental status)
Data sourced from ClinicalTrials.gov (NCT03583385). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.