GXR RM China BE Study (Darmstadt - Jiangsu)

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Reference Glucophage® XR; Drug: Test Glucophage® XR

Study type: Interventional

Funder types: Industry

Identifiers

NCT05463094

MS200084_0030

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 .

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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84 participants in 4 patient groups

First Test GXR RM (Fasted), Then Reference GXR RM (Fasted)

Experimental group

Description:

Participants 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.

Treatment:

Drug: Test Glucophage® XR

Drug: Reference Glucophage® XR

First Reference GXR RM (Fasted), Then Test GXR RM (Fasted)

Experimental group

Description:

Participants 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.

Treatment:

Drug: Test Glucophage® XR

Drug: Reference Glucophage® XR

First Test GXR RM (Fed), Then Reference GXR RM (Fed)

Experimental group

Description:

Participants 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.

Treatment:

Drug: Test Glucophage® XR

Drug: Reference Glucophage® XR

First Reference GXR RM (Fed), Then Test GXR RM (Fed)

Experimental group

Description:

Participants 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.

Treatment:

Drug: Test Glucophage® XR

Drug: Reference Glucophage® XR