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Test Glucophage

Phase 1

Healthy | Small molecule | Other |Merck KGaA|Last Updated: Apr 14, 2023

Target and mechanism

ModalitySmall molecule

Also known as Test Glucophage® XR, Glucophage® XR Reference, Glucophage Reference

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment84

FDA Designations

No designations recorded

Clinical trial landscape

Test Glucophage · 1 trial · 1 indication

Phase 1 1
NCT05463094GXR RM China BE Study (Darmstadt - Jiangsu)Healthy
COMPLETED84 Analytics
PHASE1COMPLETED
GXR RM China BE Study (Darmstadt - Jiangsu)
Healthy
NCT0546309484
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Study Endpoints

Primary Endpoints

Area Under the Plasma Concentration-time Curve From Time Zero to the Last Sampling Time at Which the Concentration is at or Above the Lower Limit of Quantification (AUC0-t) of Metformin
Pre-dose up to 48 hours post-dose on Day 1 and Day 8
Maximum Observed Plasma Concentration (Cmax) of Metformin
Pre-dose up to 48 hours post-dose on Day 1 and Day 8

Secondary Endpoints

Pharmacokinetic Plasma Concentrations of Metformin
Pre-dose up to 48 hours post-dose on Day 1 and Day 8
Number of Participants with Treatment-Emergent Adverse Events (AEs)
Baseline up to Day 10
Number of Participants with Abnormal Laboratory Variables, Vital Signs and 12-Lead Electrocardiogram (ECG) Measurements and Physical Examination
Baseline up to Day 10
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
First Test GXR RM (Fasted), Then Reference GXR RM (Fasted)EXPERIMENTALParticipants will receive a single dose of Test Glucophage Extended Release Reduced Mass (GXR RM) tablet on Day 1 in treatment period 1 followed by a single dose of Reference GXR RM tablet on Day 8 in treatment period 2 under fasted condition. There will be separate washout period of 7 days between each treatment period.
First Reference GXR RM (Fasted), Then Test GXR RM (Fasted)EXPERIMENTALParticipants will receive a single dose of Reference GXR RM tablet on Day 1 in treatment period 1 followed by a single dose of Test GXR RM tablet on Day 8 in treatment period 2 under fasted condition. There will be separate washout period of 7 days between each treatment period.
First Test GXR RM (Fed), Then Reference GXR RM (Fed)EXPERIMENTALParticipants will receive a single dose of Test GXR RM tablet on Day 1 in treatment period 1 followed by a single dose of Reference GXR RM tablet on Day 8 in treatment period 2 under fed condition. There will be separate washout period of 7 days between each treatment period.
First Reference GXR RM (Fed), Then Test GXR RM (Fed)EXPERIMENTALParticipants will receive a single dose of Reference GXR RM tablet on Day 1 in treatment period 1 followed by a single dose of Test GXR RM tablet on Day 8 in treatment period 2 under fed condition. There will be separate washout period of 7 days between each treatment period.

Interventions

NameTypeDescription
Test Glucophage® XRDRUGParticipants will receive single oral dose of Test GXR RM tablet under fasted or fed conditions.
Reference Glucophage® XRDRUGParticipants will receive single oral dose of Reference GXR RM tablet under fasted or fed conditions.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participants who are overtly healthy as determined by medical evaluation, including medical history, ECG recording and physical examination judged by investigator. * Participants with a body weight within 50 to 90 kg (kilogram) and BMI (body mass index) within the range 19 to ...

Countries:Germany
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