Randomized, Crossover Trial

An Open Label, Balanced, Randomized, Single-Dose, Two-Treatment, Two-Sequence, Two-Period, Crossover Oral Bioequivalence Study Comparing Gliclazide and Metformin Extended Release Tablets 60 mg / 500 mg manufactured by Servier India Private Limited with Glycinorm M OD (Gliclazide Modified Release and Metformin Extended Release Tablets 60 mg / 500 mg) Tablets (Indian innovator) Manufactured by IPCA Laboratories, India in Healthy, Adult, Human Male Subjects Under Fasting Conditions. - BA/BE Study

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/02/049496

Enrollment

Registered

2023-02-07

Start date

Unknown

Completion date

Unknown

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Test Product- Gliclazide and Metformin Extended Release Tablets 60 mg / 500mg manufactured by Servier India Private Limited.: Subjects will be housed in the clinical facility from at le

Eligibility

Inclusion criteria

Inclusion criteria: Healthy male human adult subjects (of 18 to 45 years of age (both inclusive) and weight of at least 50 kg. Capable and willing to give informed written consent and to adhere to the study requirements. Body Mass Index (BMI) between 18.50 30.00 Kg/m2. Healthy individuals as evaluated by personal history, medical history and general clinical examination. Absence of significant disease or clinically significant abnormal laboratory values or laboratory evaluation, medical history or physical examination judged by investigator. Normal biochemical, haematological and urinary parameters or with abnormality considered to be clinically not significant and performed within 21 days prior to dosing of first period of the study. Have a normal 12 lead ECG or with an abnormality considered to be clinically not significant. Negative HIV 1 & 2 antibodies, Hepatitis B surface antigen, Hepatitis C antibody and Syphilis. Non-smoker (for at least 6 months prior to first drug administration). Ability to fast for at least 14.00 hours and consume standard meals.

Exclusion criteria

Exclusion criteria: History of any medical disorder that is of significance in the invesigators opinion. Recent history of urinary retention, severe gastro-intestinal condition (including toxic mega colon), myasthenia gravis, narrow-angle glaucoma, and tachyarrhythmia. History of any major surgical procedure in the past 3 months. History of diabetes mellitus, tuberculosis and systemic hypertension. History of any medication for treatment of joint pain, inflammation, stone in kidney or urinary tract prior to one month of screening day History suggestive of cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, metabolic, psychiatric or hematological illnesses, judged to be clinically significant. Recent history of dehydration from diarrhea, vomiting or any other reason within a period of 24 hours prior to the study. History of dysphasia. History or presence of cancer. Difficulty in donating blood

Design outcomes

Primary

Measure	Time frame
To compare the rate and extent of absorption of Gliclazide and Metformin from Gliclazide and Metformin Extended Release Tablets 60 mg / 500 mg tablets manufactured by Servier India Private Limited (Test Product) and Glycinorm M OD (Gliclazide Modified Release and Metformin Extended Release Tablets 60 mg / 500mg) tablets manufactured by IPCA Laboratories, India in healthy, adult, human male subjects under fasting conditionsTimepoint: 17 days	—

Measure

Time frame

To compare the rate and extent of absorption of Gliclazide and Metformin from Gliclazide and Metformin Extended Release Tablets 60 mg / 500 mg tablets manufactured by Servier India Private Limited (Test Product) and Glycinorm M OD (Gliclazide Modified Release and Metformin Extended Release Tablets 60 mg / 500mg) tablets manufactured by IPCA Laboratories, India in healthy, adult, human male subjects under fasting conditionsTimepoint: 17 days

—

Secondary

Measure	Time frame
To monitor the safety and tolerability of a single dose administered in healthy,adult, human male subjects under fasting conditions.Timepoint: Day 1 to Day 17	—

Countries

India

Contacts

Public ContactDrNageshwar HulgundeMBBS

BioRadius Therapeutic Research Pvt. Ltd

nageshwarhulgunde@bioradiuscro.com02067789100

Outcome results