Status:
COMPLETED
A Pharmacokinetic and Bioavailability Study of 28431754 (Canagliflozin) in Healthy Male Volunteers
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Healthy
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the absolute oral bioavailability (how fast and how much study drug is absorbed in the body) of a single 300-mg oral dose of canagliflozin in healthy male volu...
Detailed Description
This is an open-label (the patient will know the identity of the treatment they receive), single-dose, single-center study to evaluate the absolute oral bioavailability (the rate and extent at which t...
Eligibility Criteria
Inclusion
- Signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study
- agrees to use an adequate contraception method as deemed appropriate by the investigator (e.g., vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
- has a blood pressure (after sitting for 5 minutes) between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
Exclusion
- Used any 14C labeled medication within 6 months before the first dose of the study drug is scheduled
- Have 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, renal or hepatic 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
- Have clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening and at admission to the study center as deemed appropriate by the investigator
- Have clinically significant abnormal physical examination, vital signs or 12 lead ECG at screening and admission to the study center as deemed appropriate by the investigator
- Used any prescription or nonprescription medication (including vitamins and herbal supplements), except for occasional use of paracetamol (a maximum of 3 doses per day of 500 mg paracetamol, and no more than 3 grams per week), within 14 days before the first dose of the study drug is scheduled
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01157000
Start Date
May 1 2010
End Date
June 1 2010
Last Update
April 8 2014
Active Locations (1)
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1
Merksem, Belgium