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 range18 Years
SexALL
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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…
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.