GXR RM China BE Study (Darmstadt - Jiangsu)

NCT ID: NCT05463094

Last Updated: 2023-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-25
• Study Completion Date: 2023-01-03

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Test Glucophage® XR

Intervention Type: DRUG

Participants will receive single oral dose of Test GXR RM tablet under fasted or fed conditions.

Reference Glucophage® XR

Intervention Type: DRUG

Participants will receive single oral dose of Reference GXR RM tablet under fasted or fed conditions.

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

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.

Group Type: EXPERIMENTAL

Test Glucophage® XR

Intervention Type: DRUG

Participants will receive single oral dose of Test GXR RM tablet under fasted or fed conditions.

Reference Glucophage® XR

Intervention Type: DRUG

Participants will receive single oral dose of Reference GXR RM tablet under fasted or fed conditions.

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

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.

Group Type: EXPERIMENTAL

Test Glucophage® XR

Intervention Type: DRUG

Participants will receive single oral dose of Test GXR RM tablet under fasted or fed conditions.

Reference Glucophage® XR

Intervention Type: DRUG

Participants will receive single oral dose of Reference GXR RM tablet under fasted or fed conditions.

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

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.

Group Type: EXPERIMENTAL

Test Glucophage® XR

Intervention Type: DRUG

Participants will receive single oral dose of Test GXR RM tablet under fasted or fed conditions.

Reference Glucophage® XR

Intervention Type: DRUG

Participants will receive single oral dose of Reference GXR RM tablet under fasted or fed conditions.

Interventions

Test Glucophage® XR

Participants will receive single oral dose of Test GXR RM tablet under fasted or fed conditions.

Intervention Type: DRUG

Reference Glucophage® XR

Participants will receive single oral dose of Reference GXR RM tablet under fasted or fed conditions.

Intervention Type: DRUG

Other Intervention Names

Metformin hydrochloride; Metformin hydrochloride

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Locations

Research Site

Darmstadt, , Germany

Countries

Germany

Related Links

https://clinicaltrials.emdgroup.com/en

Trial Awareness and Transparency website

https://www.merckgroup.com/en/company/contact-us/medinfo-contact-map.html

Medical Information Location Map - Med Info Contacts

Other Identifiers

MS200084_0030

Identifier Type: -

Identifier Source: org_study_id