Open-label, Randomized, Two-way Crossover, Two-sequence, Two-period, Two-treatment Bioequivalence Study of Dapagliflozin Tablet 10 mg in Healthy Thai Volunteers
- Conditions
- Bioequivalence Study,Healthy,Thai ,VolunteersDapagliflozin,
- Registration Number
- TCTR20201217001
- Lead Sponsor
- International Bio Service Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 40
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 check-in in Period 1. Injectable contraceptives e.g. Depo-Provera® will be discontinued at least 6 months prior to check-in 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 check-in in Period 1 until 7 days after the end of study in Period 2. Female subjects of non-childbearing potential must meet at least one of the following criteria prior to check-in in Period 1:
ï‚· Postmenopausal for at least 1 year or
ï‚· 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 check-in in Period 1 until 7 days after the end of study in Period 2.
7.Have voluntarily given written informed consents (signed and dated) by the subject prior to participating in this study.
1. History of allergic reaction or hypersensitivity to dapagliflozin or to any of the excipients
2.History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological (e.g. anemia), endocrine (e.g. hyper/hypothyroidism, diabetes mellitus), pulmonary or respiratory (e.g. asthma), cardiovascular (e.g. hyper/hypotension), psychiatric (e.g. depression), neurologic (e.g. convulsion), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness
3.Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19
4.Have abnormality of glucose (FBS)
5.History or evidence of type 1 diabetes mellitus, diabetic ketoacidosis
6.History or evidence of heart failure
7.History or evidence of volume depletion, hypotension, electrolyte imbalances
8.History or evidence of genital mycotic infections, urinary tract infections within 14 days prior to check-in in each period
9.History or evidence of necrotizing fasciitis of the perineum (fournier’s gangrene)
10.History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
11.History or evidence of severe hepatic impairment
12.Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy
13.History of problems with swallowing tablet or capsule
14.History of sensitivity to heparin or heparin-induced thrombocytopenia
15.History of vomiting or diarrhea within 24 hours prior to check-in in each period
16.12-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.
17.Investigation with blood sample shows positive test for anti-HIV, anti-HCV, VDRL or HBsAg
18.Abnormal liver function, ≥ 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test
19.Has renal creatinine clearance (CrCL) < 30 mL/min based on serum creatinine results, using glomerular filtration rate (GFR; Cockcroft-Gault formula), at the screening laboratory test
20.Has renal creatinine clearance (CrCL) < 30 mL/min based on serum creatinine results, using glomerular filtration rate (GFR; Cockcroft-Gault formula), at the screening laboratory test
21.Investigation with blood sample shows level of sodium less than 136 or more than 146 mmol/L at screening laboratory test.
22.Investigation with blood sample shows level of chloride less than 96 or more than 109 mmol/L at screening laboratory test.
23.Investigation with blood sample shows level of phosphate less than 3.0 or more than 4.5 mg/dL at screening laboratory test.
24.History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine)
25.History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dapagliflozin plasma concentration 0-48 hrs Cmax, AUC0-tlast and AUC0-∞
- Secondary Outcome Measures
Name Time Method Dapagliflozin plasma concentration 0-48 hrs Tmax, t1/2, AUC0-tlast/AUC0-∞, AUC%extrapolate, λz and MRT