glucose-lowering therapy glycemic control
Conditions
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Willing to adhere to the prohibitions and restrictions specified in this protocol ;- If a woman must, must be postmenopausal (age >=40 years with no spontaneous menses for at least 2 years and follicle stimulating hormone [FSH] >= 40 micro international units per milliliters [mIU/mL]), surgically sterile (hysterectomy, bilateral ophorectomy, tubal ligation, or otherwise be incapable of;pregnancy), abstinent, or, if sexually active, be practicing an effective method of birth control (example[e.g], prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) Note: For abstinent and sexually active females who are able to become pregnant and not using hormonal contraceptives, must use an effective method for birth control for 14 days before dosing and throughout the study. If a woman using a hormonal contraceptive, must be using the same hormonal contraceptive for 3 months before entry, and throughout the study;- If a woman, must have a negative urine pregnancy test at screening and on Day 1 of each Treatment Period.;- Body mass index (BMI; weight [kilogram {kg}]/height^2 [m^2]);between 18 and 30 kg/m^2 (inclusive), and body weight not less than 50 kg;- Blood pressure (an average of 3 measurements done after the subject is sitting for 5 minutes and with 5 minutes interval between measurements) between 90 and 140 per milliliters of mercury level (mm Hg), inclusive, systolic and no higher than 90 mm Hg diastolic at Screening or Day -1 of the first Treatment Period
Exclusion criteria
Exclusion criteria: - History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including;any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease,;including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the investigator considers should exclude the subject or that could interfere with the interpretation of the study results.;- Clinically significant abnormal values for hematology clinical chemistry or urinalysis at screening. These significant abnormal values for hematology, clinical chemistry, or urinalysis at screening. These;laboratory evaluations will not be performed on Day 1 of Period 1 if the Screening assessments were performed within 3 days of Day 1;- Clinically significant abnormal physical examination (Screening;only), 12-lead electrocardiogram (ECG) (Screening only) or vital signs at screening or on Day -1 of the;first Treatment Period as deemed appropriate by the investigator ;- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol, hormonal contraceptives and hormonal replacement therapy within 14 days before the first dose of the study drug is scheduled.;- History of or a reason to believe, a subject has a history of drug or alcohol abuse within the past 5 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioequivalence | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Tolerability | — |
Countries
Netherlands
Outcome results
None listed