Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Glucophage® Extended Release (XR) 750 Milligram (mg) Indonesia Bioequivalence (BE) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03583385
Recruitment Status : Completed
First Posted : July 11, 2018
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Brief Summary:
The purpose of this study is to assess bioequivalence between metformin hydrochloride (Glucophage® XR) manufactured in PT Merck Tbk, Indonesia (test drug) and metformin hydrochloride (Glucophage® XR) manufactured in Merck Santé, France (comparator drug) following single oral dose administration under fasting condition.

Condition or disease Intervention/treatment Phase
Healthy Drug: Glucophage XR (Test drug) Drug: Glucophage XR (Comparator drug) Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: A Randomized, Open-label, Two-way Crossover Study Assessing the Bioequivalence (BE) Between Single Dose of 750 mg Glucophage® XR Tablets (PT Merck Tbk, Jakarta, Indonesia-Manufactured) and 750 mg Glucophage® XR Tablets (Merck Santé, Semoy, France-Manufactured) Under Fasted State in Healthy Subjects
Actual Study Start Date : August 16, 2018
Actual Primary Completion Date : October 5, 2018
Actual Study Completion Date : October 5, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: First Test, Then Comparator Drug
Participants will receive single oral dose of Glucophage® XR tablet manufactured by PT Merck Tbk, Jakarta, Indonesia (Test Drug) followed by single oral dose of Glucophage® XR tablet manufactured by Merck Santé, Semoy, France (Comparator Drug) under fasted conditions. The two doses will be separated by a 7-day wash-out period.
Drug: Glucophage XR (Test drug)
Participants will receive single oral dose of Glucophage® XR tablet manufactured by PT Merck Tbk, Jakarta, Indonesia (Test Drug) under fasted conditions.
Other Name: Metformin hydrochloride

Drug: Glucophage XR (Comparator drug)
Participants will receive single oral dose of Glucophage® XR tablet manufactured by Merck Santé, Semoy, France (Comparator Drug) under fasted conditions.
Other Name: Metformin hydrochloride

Experimental: First Comparator, Then Test Drug
Participants will receive single oral dose of Glucophage® XR tablet manufactured by Merck Santé, Semoy, France (Comparator Drug) followed by single oral dose of Glucophage® XR tablet manufactured by PT Merck Tbk, Jakarta, Indonesia (Test Drug) under fasted conditions. The two doses will be separated by a 7-day wash-out period.
Drug: Glucophage XR (Test drug)
Participants will receive single oral dose of Glucophage® XR tablet manufactured by PT Merck Tbk, Jakarta, Indonesia (Test Drug) under fasted conditions.
Other Name: Metformin hydrochloride

Drug: Glucophage XR (Comparator drug)
Participants will receive single oral dose of Glucophage® XR tablet manufactured by Merck Santé, Semoy, France (Comparator Drug) under fasted conditions.
Other Name: Metformin hydrochloride




Primary Outcome Measures :
  1. Area Under Plasma Concentration Versus Time Curve From Administration to Last Observed Concentration at Time t (AUC0-t) [ Time Frame: Pre-dose up to 32 hours post-dose ]
  2. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Pre-dose up to 32 hours post-dose ]

Secondary Outcome Measures :
  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Day 21 ]
  2. Area Under Plasma Concentration Verses Time Curve Extrapolated to Infinity (AUC0-inf) [ Time Frame: Pre-dose up to 32 hours post-dose ]
  3. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Pre-dose up to 32 hours post-dose ]
  4. Elimination Half-life in Plasma (t½) [ Time Frame: Pre-dose up to 32 hours post-dose ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants has provided written informed consent prior to the conduct of any study-related activities
  • Body mass index of 18 to 25 kilogram per square meter (kg/m^2)
  • Good physical and mental health status, determined on the basis of medical history and physical examination
  • Vital signs (blood pressure, pulse rate, respiratory rate and body temperature) in sitting position within the normal range or showing no clinically relevant deviation per the Investigator's opinion
  • All values for laboratory assessments (hematology, clinical chemistry and urinalysis) within the normal range or showing no clinically relevant deviation per the Investigator's opinion
  • No clinically significant abnormality on 12-lead electrocardiogram (ECG) recording as judged by the Investigator; corrected QT interval (QTc) (Bazett) should be less than equals to (<=) 450 milliseconds (ms)
  • Non-smoker or smoker less than 10 cigarettes per day
  • Women of childbearing potential (WOCBP) who are not nursing, are not pregnant, and are using highly effective methods of birth control. Female participants may also be enrolled if they are postmenopausal or surgically sterilized/ hysterectomized at least 6 months prior to study participation
  • WOCBP must have a negative urine pregnancy test at Screening and on each admission (Day 1 of each dosing period)
  • Negative screen for alcohol and drugs abuse (opiate class, barbiturates, cocaine and metabolites, amphetamines, cannabinoids and benzodiazepines) at Screening and on each Study Check-In (Day -1 of each dosing period)
  • Negative screen for Hepatitis B surface antigen (HBsAg), Hepatitis C Virus (HCV) antibodies and/or Human Immunodeficiency Virus (HIV) antibodies.

Exclusion Criteria:

  • Participation in a clinical trial/study within 90 days prior to Screening
  • Blood donation (equal or more than 300 milliliter [mL]) or significant blood loss within 90 days prior to first drug administration
  • Any surgical or medical condition, including findings in the medical history or in the prestudy assessments, or any other significant disease, that in the opinion of the investigator, constitutes a risk or a contraindication for the participation of the participant in the study or that could interfere with the study objectives, conduct or evaluation
  • History of malignant diseases, except in-situ basal cell skin tumors treated with curative intent
  • History of surgery of the gastrointestinal tract which could influence the gastrointestinal absorption and/or motility per the Investigator's opinion
  • History or presence of relevant liver diseases or hepatic dysfunction (laboratory result for liver function test greater than equals to (>=) 1.5 upper limit of normal (ULN)
  • History or presence of renal failure or renal dysfunction based on clinical symptoms and finding (serum creatinine concentration >1.4 milligram per milliliter (mg/mL)
  • Ascertained or presumptive hypersensitivity to the active drug substance and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study
  • Receipt of any prescription or non-prescription medication within 14 days before the first drug administration, except for hormonal contraceptives in female, and including multivitamins and herbal products (e.g. St John's Wort)
  • Consumption of large quantities of methylxanthine-containing beverages (> 5 cups of coffee/day or equivalent)
  • Consumption of grapefruit, orange, cranberry or juices of these three fruits, 24 hours prior to drug administration
  • Known lack of participant compliance or inability to communicate or cooperate with the Investigator (e.g., language problem, poor mental status)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03583385


Locations
Layout table for location information
Indonesia
PT Equilab International
Jakarta, Indonesia, 12430
Sponsors and Collaborators
Merck KGaA, Darmstadt, Germany
Investigators
Layout table for investigator information
Study Director: Medical Responsible PT Merck Tbk, Indonesia, and affiliate of Merck KGaA, Darmstadt, Germany

Layout table for additonal information
Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT03583385     History of Changes
Other Study ID Numbers: MS200084_0015
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs