Relative bioavailability study of two different beaches of Metformin Hydrochloride Prolonged Release Tablets 1000 mg relative to reference of Glucophage SR 1000 mg Prolonged Release Tablets (Metformin Hydrochloride) in healthy male and female volunteers under fed conditions
- Registration Number
- CTRI/2019/04/018527
- Lead Sponsor
- Indoco Remedies Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Subject aged between 18 to 45 years (both inclusive).
2.Willing to abstain from use of any prescription and over the counter medications (vitamins and minerals through duration of the study) including medications which may interfere with pharmacokinetics of Metformin.
3.Subject weight within clinically acceptable range according to normal values for Body-mass index of 18.5 kg/m2 to 30.0 kg/m2, with body weight not less than 50 kg
4.Subject with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable normal range
5.Subject having clinically acceptable 12-lead electrocardiogram (ECG).
6.Subject having clinically acceptable chest X-ray (P/A view).
7.Comprehension of the nature and purpose of the study and compliance with the requirement of the protocol.
8.Subject having negative urine screen for drugs of abuse (including Morphine, Benzodiazepines, Tetra Hydro Cannabinoids (THC), Barbiturates, Cocaine and Amphetamines).
9.Subject having negative alcohol breath test.
10.Non-smokers and non-alcoholics.
11.Subject willing to adhere to the protocol requirements and to provide written informed consent.
12.Female Subjects
12.1 Subject having negative serum β-hCG test (only for female volunteers).
12.2 of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence, or
12.3 post-menopausal for at least 1 year, or
12.4 surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).
1.Personal / family history of allergy or hypersensitivity to Metformin & its excipients and related drug.
2.History of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis), Diabetic pre-coma and severe renal failure.
3.History of tissue hypoxia (Decompensated heart failure, Respiratory failure recent myocardial infarction and shock)
4.History of hepatic insufficiency, acute alcohol intoxication and alcoholism.
5.Past history of anaphylaxis or angioedema.
6.History or presence of significant smoking.
7.Presence of drug abuse.
8.History of major illness in the past three months or any clinically significant on-going chronic medical illness e.g., congestive heart failure, hepatitis, pancreatitis etc.
9.Known or suspected increased susceptibility to infection.
10.Presence of any clinically significant abnormal values during screening e.g. significant abnormality of Liver Function Test (LFT), Renal (kidney) Function Test (RFT), etc.
11.History of cardiac, renal or liver disease resulting in liver impairment, any other organ or system impairment.
12.History of seizure or psychiatric disorders.
13.Presence of disease markers of HIV 1 and 2, and hepatitis B and C virus.
14.Consumption of xanthine containing derivatives (coffee, tea, cola drinks, chocolate). within 48 hours before check-in and through duration of the study.
15.History of any usage of recreational drug or a history of drug addiction.
16.History of participation in any clinical trial within the past 3 months.
17.Inaccessibility of veins in left and right arm.
18.History of donation of blood (one unit or 330 mL) within 3 months prior to check-in
19.Use of any prescribed or OTC medicinal products including vitamins and minerals during the within two weeks prior to investigational products administration in period.
20.History of unusual diet, for whatever reason e.g. low sodium diet, for two weeks prior to check-in
21.History of consumption of grapefruit- containing food or beverages within 48 hours prior to the check-in.
22.Recent history of dehydration from diarrhoea, vomiting or any other reason within a period of 7 days prior to check-in.
23.Female volunteers demonstrating a positive test for pregnancy during screening or currently breast-feeding.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the single oral dose bioequivalence of test products (T1 and T2) Metformin Hydrochloride Prolonged Release Tablets 1000 mg of Indoco Remedies Limited, India with that of reference product (R) Glucophage SR 1000 mg Prolonged Release Tablets (Metformin Hydrochloride) of Merck Serono Ltd, UK in healthy, adult, human subjects under fed conditions. <br/ ><br>Plasma PK parameters including Cmax, AUC0-12, AUC12-24, AUC0-t and AUC0-â?? for Metformin in relevant treatmentsTimepoint: Twenty five (25) blood samples (1 x 4 mL) will be collected in pre-labelled K2 EDTA vacutainers. Single venous blood sample will be withdrawn at pre-dose (0.00) and 0.50, 1.00, 2.00, 3.00, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 7.50, 8.00, 8.50, 9.00, 10.00, 11.00, 12.00, 14.00, 16.00, 18.00, 20.00, 22.00 and 24.00 hours post-dose
- Secondary Outcome Measures
Name Time Method To characterise secondary PK parameters of test formulations of Metformin Hydrochloride Prolonged Release Tablets relative to reference Glucophage SR 1000 mg Prolonged Release Tablets in healthy human subjects under fed conditions. <br/ ><br> <br/ ><br>Plasma PK parameters: Tmax, t1/2, Kel and AUC_% Extrap_Obs <br/ ><br> <br/ ><br>Safety and tolerability of all treatments as assessed by blood pressure and pulse rate measurements, review of adverse events and clinical laboratory safety dataTimepoint: Twenty five (25) blood samples (1 x 4 mL) will be collected in pre-labelled K2 EDTA vacutainers. Single venous blood sample will be withdrawn at pre-dose (0.00) and 0.50, 1.00, 2.00, 3.00, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 7.50, 8.00, 8.50, 9.00, 10.00, 11.00, 12.00, 14.00, 16.00, 18.00, 20.00, 22.00 and 24.00 hours post-dose