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Completed

NCT Number: NCT05463094

GXR RM China BE Study (Darmstadt - Jiangsu)

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Darmstadt, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Test Glucophage® XR

Drug

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

Other names: Metformin hydrochloride

Reference Glucophage® XR

Drug

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

Other names: Metformin hydrochloride

Primary outcomes

  1. 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

    Time frame: Pre-dose up to 48 hours post-dose on Day 1 and Day 8

  2. Maximum Observed Plasma Concentration (Cmax) of Metformin

    Time frame: Pre-dose up to 48 hours post-dose on Day 1 and Day 8

Secondary outcomes

  1. Pharmacokinetic Plasma Concentrations of Metformin

    Time frame: Pre-dose up to 48 hours post-dose on Day 1 and Day 8

  2. Number of Participants with Treatment-Emergent Adverse Events (AEs)

    Time frame: Baseline up to Day 10

  3. Number of Participants with Abnormal Laboratory Variables, Vital Signs and 12-Lead Electrocardiogram (ECG) Measurements and Physical Examination

    Time frame: Baseline up to Day 10

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 18, 2022
Registry last updated
Apr 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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