Clinical trial NCT05463094: GXR RM China BE Study (Darmstadt - Jiangsu)
Official title: A Randomized, Open-label, 2-Way-Crossover Study Assessing the Bioequivalence Between Single Doses of 500 mg Glucophage® XR RM Tablets (Merck/China Jiangsu-Manufactured) and 500 mg Glucophage® XR RM Tablets (Merck/Germany Darmstadt-Manufactured) Under Fed and Fasted State in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence
Glucophage® XR RM
Lead sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2022-07-18
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess Bioequivalence (BE), pharmacokinetics (PK), safety and tolerability following single oral dose administrations between a Glucophage Extended Release, Reduced Mass (Glucophage XR RM) manufactured in Merck Jiangsu China (test product) and that manufactured in Merck Darmstadt Germany (reference product) administered under fasted and fed conditions.


Eligibility criteria: 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 26 kg/m2 (kilogram per meter square).
* Participants with 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.
* Other protocol defined inclusion criteria could apply.

Exclusion Criteria:

* Participants with any surgical or medical condition, including findings in the medical history or in the pretrial assessments, or any other significant disease, that in the opinion of the Investigator, constitutes a risk or a contraindication for the participation in the study or that could interfere with the study objectives, conduct or evaluation.
* Participants with history or presence of relevant liver diseases or hepatic or renal dysfunction.
* Participants with history of surgery of the gastrointestinal tract which could influence the gastrointestinal absorption and/or motility according to the Investigator's opinion.
* Participation in a clinical study within 90 days prior to first drug administration.
* Non-acceptance of study high-fat breakfast.
* Other protocol defined exclusion criteria could apply .

Primary outcomes:
measure: 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
timeFrame: Pre-dose up to 48 hours post-dose on Day 1 and Day 8
measure: Maximum Observed Plasma Concentration (Cmax) of Metformin
timeFrame: Pre-dose up to 48 hours post-dose on Day 1 and Day 8
Secondary outcomes:
measure: Pharmacokinetic Plasma Concentrations of Metformin
timeFrame: Pre-dose up to 48 hours post-dose on Day 1 and Day 8
measure: Number of Participants with Treatment-Emergent Adverse Events (AEs)
timeFrame: Baseline up to Day 10
measure: Number of Participants with Abnormal Laboratory Variables, Vital Signs and 12-Lead Electrocardiogram (ECG) Measurements and Physical Examination
timeFrame: Baseline up to Day 10
Other outcomes:
Locations:
city: Darmstadt
country: Germany
facility: Research Site
Study officials:
affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: