Phase 1
Completed N=54
Glucophage Extended Release (GXR) China Bioequivalence Study (Nantong - Darmstadt)
Healthy
Source: ClinicalTrials.gov NCT03566810 ↗
Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcomePrimary: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-t) of Metformin — 3740; 3780; 5500; 5540 nanogram*hour per milliliter (ng*h/mL)
Summary
The study will assess the bioequivalence between single doses of GXR manufactured in Merck Nantong China (test drug) and GXR manufactured in Merck Darmstadt Germany (reference drug) under fed and fasted state in healthy participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-t) of Metformin |
3740; 3780; 5500; 5540 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of Metformin |
572; 578; 519; 536 | — |
| SECONDARY Time to Reach Maximum Plasma Concentration of Metformin |
3.00; 4.00; 6.00; 6.00 | — |
| SECONDARY Apparent Terminal Half-Life (t1/2) of Metformin |
5.80; 5.56; 5.34; 5.37 | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Metformin |
3890; 3980; 5630; 5750 | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve From Time Tlast Extrapolated to Infinity (AUCextra) of Metformin |
— | — |
| SECONDARY Elimination Rate Constant (Lambda z) of Metformin |
— | — |
| SECONDARY Total Body Clearance (CL/f) of Metformin |
128; 126; 88.9; 87.0 | — |
| SECONDARY Apparent Volume of Distribution at After Extravascular Administration (Vz/f) of Metformin |
1070; 1010; 684; 674 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs |
10; 11; 3; 4; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Vital Signs |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Laboratory Values |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in Physical Examination Findings |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities in 12-lead Electrocardiogram (ECG) Findings |
0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Overtly healthy as determined by medical evaluation, including medical history and a physical examination
- Have a body weight within 50 to 90 kilogram (kg) and Body mass index (BMI) within the range 18 to 30 kg per meter square (kg/m^2) (inclusive)
- Chinese male and female (at least 1/4 of each gender per study group)
- A male participant must agree to use and to have their female partners use a highly effective contraception (that is, methods with a failure rate of less than 1 percent per year) for a period of at least 1 month before and after dosing
- A female is eligible if she is not pregnant (that is, after a confirmed menstrual period and a negative serum pregnancy test), not breastfeeding, and at least one of the following conditions applies
- Is not a woman of childbearing potential (WOCBP) OR
- Is a WOCBP who agrees to use a highly effective contraceptive method (that is, has a failure rate of less than 1 percent per year) for a period of at least 1 month before and after dosing
- Can give signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol
- Non-smoker (0 cigarettes, pipes, cigars, or others) since at least 3 months
- All values for biochemistry and hematology tests of blood and urine within the normal range or showing no clinically relevant deviation as judged by the Investigator
- Electrocardiogram recording (12 lead ECG) without signs of clinically relevant pathology as judged by the Investigator.
- Pulse, body temperature, and respiration in sitting position within the normal range or showing no clinically relevant deviation as judged by the Investigator. Blood pressure in sitting position within normal range: greater than or equals to (>=) 90 millimeter of mercury (mmHg) and less than or equal to (= = 60 mmHg and = 5 cups of coffee/day or equivalent)
- Consumption of grapefruit, cranberry, or juices of these fruits, from 14 days prior to drug administration until collection of the last Pharmacokinetics sample in Period 2
- Any contraindication to Glucophage
- Abnormal and clinically significant chest X-ray finding at screening
Data sourced from ClinicalTrials.gov (NCT03566810). 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. Informational only — not medical advice.