The purpose of this studie is to evaluate the bioequivalence of canagliflozin.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Bioequivalence
Secondary outcome
Safety
Tolerability
Background summary
A new polymorph for canagliflozin (canagliflozin monohydrate) was recently
discovered. Since this is a new form, there is no information available on its
clinical bioavailability. Results from this study and the comparison to the
hemihydrate form (used in the currently marketed tablets) will provide an
understanding of the bioavailability of the canagliflozin monohydrate form and
also provide useful guidance around active pharmaceutical ingredient (API)
process control requirements.
Based on physiologic based dissolution testing and in silico modeling using
Gastroplus, the 100% monohydrate form is predicted to be bioequivalent to the
100% hemihydrate form. The results from this study will also confirm the
predictions based on the Gastroplus modeling.
Study objective
The purpose of this studie is to evaluate the bioequivalence of canagliflozin.
Study design
This is a randomized, open-label, single-center, single-dose, 4-treatment,
4-way crossover study in 44 healthy adult participants. The study onsists of 3
phases: a Screening Phase of approximately 3 weeks (Days -22 to -2), an
Open-Label Treatment Phase consisting of 4 single-dose Treatment
Periods of 5 days each (Days -1 through 4) separated by a washout of 7 days (1
day) between Day 1 of each Treatment Period, and a Follow-up Phase occurring 5
to 7 days after the last study-related procedure on Day 4 the last Treatment
Period.
Intervention
The study will start with a screening visit. During the screening visit
standard medical assessments including safety laboratory tests (blood draw,
urine collection), an alcohol breath test, urine drug screen, a physical
examination, ECG and a vital signs measurement will be performed.
After the subject passes all above mentioned tests,the subject will be enrolled
in the study.
During study the subject will enter the clinic. In P1-P4, the subjects will
receive 1 medication once on day 1. Subjects will be asked on a regular basis
for possible side effects, blood will be drawn for PK/PD (glucose) and the
vital signs will be checked during the 4 confinement periods. Finally a
follow-up examination will be performed. During this visit the subjects will be
asked for possible side effects, blood and urine be collected for safety, the
vital signs/ECG will be checked and a physical examination will be conducted.
Study burden and risks
Side effects that have been seen with, or are more likely to occur with,
canagliflozin include:
• Dizziness or lightheadedness upon standing
• Increased urination and thirst
• Urinary tract infections
• Allergic reaction including rash or hives
• Constipation
• Nausea
• Changes in laboratory values have been observed in clinical studies with
canagliflozin
• Bone fractures may occur in up to 1 in 50 people per year on canagliflozin.
• Diabetic ketoacidosis (increased levels of blood acids called ketones)
For Women:
• Vaginal yeast infections and vaginal itching
For Men:
• Yeast infection at the head of the penis
Turnhoutseweg 30
Beerse 2340
BE
Turnhoutseweg 30
Beerse 2340
BE
Listed location countries
Age
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
- 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2015-003176-79-NL |
CCMO | NL54545.056.15 |