Phase 1
Completed N=80
Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Non-Fasting Conditions
Healthy
Source: ClinicalTrials.gov NCT01149473 ↗
Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Sep 2010
Primary outcomePrimary: Cmax of Losartan(Maximum Observed Concentration of Drug Substance in Plasma) — 458.29; 409.324 ng/mL
Summary
The objective of this study is to compare the relative bioavailability of Losartan potassium/Hydrochlorothiazide 100/25 mg tablets (manufactured by Teva Pharmaceutical Industries, Ltd. and distributed by Teva Pharmaceuticals USA) with that of Hyzaar® 100/25 mg tablets (Merck) in healthy, adult, non-smoking subjects under non-fasting conditions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax of Losartan(Maximum Observed Concentration of Drug Substance in Plasma) |
458.29; 409.324 | — |
| PRIMARY AUC0-t of Losartan(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) |
959.41; 939.492 | — |
| PRIMARY AUC0-inf of Losartan(Area Under the Concentration-time Curve From Time Zero to Infinity) |
957.445; 956.046 | — |
| PRIMARY Cmax of Hydrochlorothiazide(Maximum Observed Concentration of Drug Substance in Plasma) |
136.361; 132.717 | — |
| PRIMARY AUC0-t of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) |
917.034; 919.631 | — |
| PRIMARY AUC0-inf of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Infinity) |
943.22; 945.592 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy, non-smoking, male and female subjects at least 18 years of age.
- BMI (body mass index) of 30 or less.
- Females in this study must be physically unable to become pregnant (postmenopausal for at least 6 months or surgically sterile).
- Successful completion of a physical examination within 28 days of initiation of the study.
- Negative serum pregnancy test (females).
Exclusion Criteria
- Subjects with a significant recent history of chronic alcohol consumption (past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic, or cardiovascular disease, tuberculosis, epilepsy, asthma (past 5 years), diabetes, psychosis, or glaucoma will not be eligible for this study.
- Subjects whose clinical laboratory test values are outside the reference range and are deemed clinically significant by the Principle Investigator.
- Subjects who have a history of allergic responses to the classes of drugs being tested will be excluded from the study.
- Subjects who use tobacco in any form will not be eligible to participate in the study. 3 months abstinence is required.
- Subjects found to have urine concentrations of any of the tested drugs of abuse will not be allowed to participate.
- Subjects should not have donated blood and/or plasma for at least 30 days prior to the first dosing of the study.
- Subjects who have taken any investigational drug within 30 days prior to the first dosing of the study will not be allowed to participate.
- Female subjects who are pregnant or who are able (women with child bearing potential) to become pregnant during the study will not be allowed to participate.
- All female subjects will be screened for pregnancy at check-in each study period. Subjects with positive or inconclusive results will be withdrawn from the study.
- Subjects who do not tolerate venipuncture will not be allowed to participate.
Data sourced from ClinicalTrials.gov (NCT01149473). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.