Losartan 100 mg Tablet in Healthy Subjects Under Non-Fasting Conditions (NCT01124175) | Clinical Trial Compass
CompletedPhase 1
Losartan 100 mg Tablet in Healthy Subjects Under Non-Fasting Conditions
Canada80 participantsStarted 2003-10
Plain-language summary
The objective of this study is to compare the rate and extent of absorption of losartan 100 mg tablets (test) versus Cozaar® (reference), administered as 1 \* 100 mg tablet under fed conditions.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Non-child-bearing potential female or male.
* Non-smoker
* 18 years or age and older.
* Capable of consent.
* Non-child-bearing potential female subject:
* Post-menopausal state: absence of menses for 12 months prior to drug administration.
* Surgically sterile: hysterectomy, bilateral oophorectomy, or tubal ligation at least 6 months prior to drug administration.
Exclusion Criteria:
* Clinically significant illness within 4 weeks prior to the administration of the study medication.
* Clinically significant surgery within 4 weeks prior to the administration of the study medication.
* Any clinically significant abnormality found during medical screening.
* Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the subject from participating in the study.
* Abnormal laboratory tests judged clinically significant.
* Positive urine drug screen at screening.
* ECG abnormalities (clinically significant) or vital sign abnormalities at screening.
* Subjects with BMI greater than or equal to 30.0.
* History of significant alcohol abuse within 6 months prior to the screening visit or any indication of the regular use of more than 14 units of alcohol per week (1 unit equals 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol).
* History of drug abuse of use of illegal drugs: use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine \[PCP\], or crack) within 1…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cmax of Losartan (Maximum Observed Concentration of Drug Substance in Plasma)
Timeframe: Blood samples collected over a 24 hour period.
2
AUC0-t of Losartan (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Timeframe: Blood samples collected over a 24 hour period.
3
AUC0-inf of Losartan (Area Under the Concentration-time Curve From Time Zero to Infinity)
Timeframe: Blood samples collected over a 24 hour period.