Bioequivalence study of gliclazide 60 mg modified release tablets under fasting conditions
- Registration Number
- CTRI/2021/01/030614
- Lead Sponsor
- Centaur Pharmaceuticals Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 76
(i)Healthy, Indian, male, human volunteers aged from 18 to 45 years.
(ii)Body mass index should be within 18.0â??24.75 kg/m2 [weight in kg / (height in m)2].
(iii)Voluntarily willing and capable to give written and signed informed consent prior to participation in the study, according to the form attached in appendix â?? 1.
(iv)Availability for the entire study period and willingness to adhere to the protocol and study requirements.
(v)Willing to undergo pre- and post-study physical examinations and laboratory investigations.
(vi)Having no significant disease or abnormal laboratory values on laboratory examination with no clinical relevance, medical history or physical examination during screening.
(vii)12-lead supine ECG in resting position and vital signs are within normal limits or showing no abnormalities, which the investigator does not consider of clinical relevance.
(viii)Normal chest X-ray findings or findings that have no clinical correlation.
(ix)Having not consumed alcohol at least 48 hrs. prior to admission in the study justified by negative breath-alcohol test and who agree not to consume any amount of alcohol throughout the conduct of the study.
(x)Negative urine test for drug of abuse (amphetamine, barbiturate, tetrahydrocannabinoids, morphine, cocaine, benzodiazepine).
(xi)Having not consumed grapefruit or orange or citrus fruits/ juice/products within 48 hrs. before IMP administration.
(xii)Non-smokers [Definition â?? Those who do not have history of smoking or having quit smoking for more than 3 years].
(i)History of allergy or sensitivity to gliclazide, or history of any drug hypersensitivity or intolerance, which, in the opinion of the investigator, would compromise the safety of the subject or the study.
(ii)History or presence of clinically relevant systemic disease such as renal, hepatic, cardiovascular, endocrine, or metabolic disorder (e.g. diabetes mellitus), malignancy, or immunodeficiency disorder.
(iii)Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study and/or likely to cause death within the study duration.
(iv)Irregular mealtimes, skipping meals, periods of fasting or dietary changes.
(v)Elevated serum transaminases (SGOT/ SGPT) or alkaline phosphatase [at least 1.5 times of upper normal range].
(vi)G6PD deficiency proved by qualitative test.
(vii)Participation in another clinical study or a blood donation program or having had blood loss of more than 350 mL during the last 90 days.
(viii)Renal insufficiency (serum creatinine more than twofold of >3 mg/dL).
(ix)Seropositive for VDRL, HIV or hepatitis B or C infection.
(x)Any clinically significant abnormality (to be determined by the investigator) following review of screening laboratory data and full physical examination.
(xi)Vital sign abnormalities [systolic blood pressure < 100 or > 140 mmHg or diastolic blood pressure < 60 or > 90 mmHg or heart rate <60 bpm or >100 bpm, or oral temperature < 95.8ºC or > 99.0ºC] at the pre-admission physical examination.
(xii)Having suffered any illness within a week of starting the study or who have been hospitalized within the 3 months preceding the start of the study.
(xiii)Any other clinical condition, which might affect the absorption, distribution, biotransformation or excretion of the study drug.
(xiv)Having taken OTC or prescribed medications, including any enzyme-modifying drugs or any systemic medication, within the last 7 days prior to the study. (However, Paracetamol may be permitted up to 3 days prior to the start of the study.)
(xv)Having a history of alcohol or substance abuse within the last 5 years.
(xvi)Habit of chewing or inhaling nicotine-containing products.
(xvii)Abnormal INR combined with clinical manifestation.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the bioavailability of test formulation and Reference formulation following single-dose administration of one tablet of test or reference formulation in healthy, adult, male, human subjects under fasted conditions with a washout period of at least 14 days between each administration, by means of rate and extent of absorptionTimepoint: To compare the bioavailability of test formulation and Reference formulation following single-dose administration of one tablet of test or reference formulation in healthy, adult, male, human subjects under fasted conditions with a washout period of at least 14 days between each administration, by means of rate and extent of absorption
- Secondary Outcome Measures
Name Time Method To monitor the safety of the participating subjects in this bioequivalence study determined by means of clinical biochemistry, physical examination and AE/SAE monitoringTimepoint: Throughout the study