GXR RM China BE Study (Darmstadt - Jiangsu)

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05463094
• Other study ID #: MS200084_0030
• Status: Completed
• Phase: Phase 1
• Start date: July 25, 2022
• Est. completion date: January 3, 2023

Study information

• Verified date: April 2023
• Source: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: January 3, 2023
• Est. primary completion date: January 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 .

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Test Glucophage® XR
Participants will receive single oral dose of Test GXR RM tablet under fasted or fed conditions.
• Reference Glucophage® XR
Participants will receive single oral dose of Reference GXR RM tablet under fasted or fed conditions.

Locations

Country	Name	City	State
Germany	Research Site	Darmstadt

Sponsors (1)

Lead Sponsor	Collaborator
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Maximum Observed Plasma Concentration (Cmax) of Metformin		Pre-dose up to 48 hours post-dose on Day 1 and Day 8
Secondary	Pharmacokinetic Plasma Concentrations of Metformin		Pre-dose up to 48 hours post-dose on Day 1 and Day 8
Secondary	Number of Participants with Treatment-Emergent Adverse Events (AEs)		Baseline up to Day 10
Secondary	Number of Participants with Abnormal Laboratory Variables, Vital Signs and 12-Lead Electrocardiogram (ECG) Measurements and Physical Examination		Baseline up to Day 10

External Links

•   Trial Awareness and Transparency website