GXR RM China BE Study (Darmstadt - Jiangsu)

NCT05463094 | Completed Phase 1

• 1 other identifier: MS200084_0030
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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

Keywords

Bioequivalence; Glucophage® XR RM

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (4)

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

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

Interventions

Test Glucophage® XR DRUG

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

Also known as: Metformin hydrochloride

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

Reference Glucophage® XR DRUG

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

Also known as: Metformin hydrochloride

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Research Site

Darmstadt, Germany

Location

Related Links

• Trial Awareness and Transparency website
• Medical Information Location Map - Med Info Contacts

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Medical Responsible

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 18, 2022
• Study Start: July 25, 2022
• Primary Completion: January 3, 2023
• Study Completion: January 3, 2023
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)