A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Gliclazide 60 mg Modified Release Tablets and Reference Product (DIAMICRON® MR 60mg) in Healthy Thai Volunteers under Fasting Conditions - Pilot Study
- Conditions
- Healthy Thai Volunteers
- Registration Number
- TCTR20180517004
- Lead Sponsor
- International Bio Service
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 8
1.Healthy Thai male or female subjects between the ages of 18 to 55 years.
2.Body mass index between 18.0 to 30.0 kg/m2.
3.Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening. Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study.
4.Non-pregnant woman (negative pregnancy test) and not currently breast feeding.
5.Female subjects abstain from either hormonal methods of contraception (including oral or transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) or hormone replacement therapy for at least 28 days prior to admission in Period 1. Injectable contraceptives e.g. Depo-Provera® will be discontinued at least 6 months prior to admission in Period 1. Subjects agree to use acceptable non-hormonal contraceptive methods such as condom, diaphragm, foams, jellies, or abstinence for at least 14 days prior to admission in Period 1 until 7 days after the end of study. Female subjects of non-childbearing potential must meet at least one of the following criteria prior to admission in Period 1:
-Postmenopausal for at least 1 year or
-Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) at least 6 months
6.Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after admission in Period 1 until 7 days after the end of study.
7.Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study.
1.History of allergic reaction or hypersensitivity to gliclazide, other sulfonylurea, sulfonamides or to any of the excipients
2.History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological, endocrine e.g. thyroid, pulmonary, cardiovascular, psychiatric, neurologic e.g. convulsion, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness
3.History or evidence of family diabetes
4.History or evidence of diabetes, diabetic pre-coma and coma, diabetic keto-acidosis
5.History or evidence of serious infection, trauma or surgery within 7 days prior to admission in each period
6.History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
7.History or evidence of glucose-6-phosphate dehydrogenase deficiency (G6PD)
8.History of problems with swallowing tablet or capsule
9.History of sensitivity to heparin or heparin-induced thrombocytopenia
10.Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy
11.History of preceding diarrhea within 24 hours prior to admission in each period
12.History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine)
13.12-lead ECG demonstrating QTc >450 msec, a QRS interval >120 msec or with an abnormality considered clinically significant at screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG will be repeated two more times and the average of the three QTc or QRS values will be used to determine the subject’s eligibility.
14.Investigation with blood sample shows positive test for HBsAg.
15.Investigation with blood sample shows fasting blood glucose level less than 70 mg/dl or more than 99 mg/dl at screening laboratory test
16.Abnormal liver function, ≥ 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test
17.History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period
18.History or evidence of alcoholism, regular alcohol consumption or alcohol-containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period
19.History or evidence of habitual consume of tea, coffee, xanthine or caffeine containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period
20.Consume or drink juice of grapefruit or orange or pomelo or its supplement/containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period
21.Use of prescription or nonprescription drugs (e.g. paracetamol, erythromycin, ketoconazole, miconazole, phenylbutazone, danazol etc.), herbal medications or supplements (e.g. St. John’s wort), vitamins or mineral (e.g. iron) or dietary supplements within 14 days prior to admission in Period 1 or during enrollment
22.P
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic evaluation 0,1,2,3,4,5,6,7,8,9,10,11,12,13,15,24,36,48,72,96 Drug concentration
- Secondary Outcome Measures
Name Time Method Safety evaluation 0-96 hr Adverse events e.g. dry mouth, headache, fatigue and somnolence