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The object of this study was to compare the relative bioavailability (rate and extent of absorption) of 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets manufactured by Teva Pharmaceutical Industries Ltd. and distributed by Teva Pharmaceuticals USA with that of Hyzaar® 100/25 mg Tablets distributed by Merck & Co., Inc. following a single oral dose (1 x 100/25 mg tablet) in healthy adult subjects administered under fasting conditions.
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA Bioequivalence Statistical Methods
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Generic Test Product | Experimental | Losartan potassium/Hydrochlorothiazide 100/25 mg Tablets |
|
| Reference Listed Drug | Active Comparator | Hyzaar® 100/25 mg Tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Losartan potassium/Hydrochlorothiazide | Drug | 100/25 mg Tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Losartan(Maximum Observed Concentration of Drug Substance in Plasma) | Bioequivalence based on Losartan Cmax. | Blood samples collected over a 48 hour period. |
| AUC0-t of Losartan(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) | Bioequivalence based on Losartan AUC0-t. | Blood samples collected over a 48 hour period. |
| AUC0-inf of Losartan(Area Under the Concentration-time Curve From Time Zero to Infinity) | Bioequivalence based on Losartan AUC0-inf. | Blood samples collected over a 48 hour period. |
| Cmax of Hydroclorothiazide(Maximum Observed Concentration of Drug Substance in Plasma) | Bioequivalence based on Hydrochlorothiazide Cmax. | Blood samples collected over a 48 hour period. |
| AUC0-t of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) | Bioequivalence based on Hydrochlorothiazide AUC0-t. | Blood samples collected over a 48 hour period. |
| AUC0-inf of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Infinity) | Bioequivalence based on Hydrochlorothiazide AUC0-inf. | Blood samples collected over a 48 hour period. |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Losartan Carboxy Acid(Maximum Observed Concentration of Drug Substance in Plasma) | Informational comparison of Cmax values for the metabolite Losartan Carboxy Acid. | Blood samples collected over a 48 hour period. |
| AUC0-t of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) |
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Inclusion Criteria:
Healthy men and women, 18-45 years of age (inclusive).
Body mass index should be less than or equal to 30
Screening procedures completed within 28 days prior to dosing.
If female and:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James D Carlson, Pharm. D. | PRACS Institute, Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRACS Institute, Ltd. | Fargo | North Dakota | 58104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Losartan/HCTZ (Test) First | 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in first period followed by 100/25 mg Hyzaar® Tablets reference product dosed in the second period. |
| FG001 | Hyzaar® (Reference) First | 100/25 mg Hyzaar® Tablets reference product dosed in first period followed by 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in the second period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
|
| ||||||||||||||||||
| Washout of 7 Days |
| |||||||||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Losartan/HCTZ (Test) First | 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in first period followed by 100/25 mg Hyzaar® Tablets reference product dosed in the second period. |
| BG001 | Hyzaar® (Reference) First |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cmax of Losartan(Maximum Observed Concentration of Drug Substance in Plasma) | Bioequivalence based on Losartan Cmax. | All participants that completed the study had their samples analyzed. | Posted | Mean | Standard Deviation | ng/mL | Blood samples collected over a 48 hour period. |
|
Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration.
Volunteers were monitored throughout the study for any adverse experiences. AEs were collected through both solicited and unsolicited methods. The volunteers were encouraged to report signs, symptoms, and any changes in health to the clinic staff.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Losartan/HCTZ (Test) | 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Biopharmaceutics | TEVA Pharmaceuticals, USA | 1-866-384-5525 | clinicaltrialqueries@tevausa.com |
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| ID | Term |
|---|---|
| C505809 | hydrochlorothiazide, losartan drug combination |
| D019808 | Losartan |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Hyzaar® |
| Drug |
100/25 mg Tablets |
|
|
Informational comparison of AUC0-t values for the metabolite Losartan Carboxy Acid. |
| Blood samples collected over a 48 hour period. |
| AUC0-inf of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Infinity) | Informational comparison of AUC0-inf values for the metabolite Losartan Carboxy Acid. | Blood samples collected over a 48 hour period. |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
100/25 mg Hyzaar® Tablets reference product dosed in first period followed by 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in the second period. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | AUC0-t of Losartan(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) | Bioequivalence based on Losartan AUC0-t. | All participants that completed the study had their samples analyzed. | Posted | Mean | Standard Deviation | ng*h/mL | Blood samples collected over a 48 hour period. |
|
|
|
|
| Primary | AUC0-inf of Losartan(Area Under the Concentration-time Curve From Time Zero to Infinity) | Bioequivalence based on Losartan AUC0-inf. | All participants that completed the study had their samples analyzed. | Posted | Mean | Standard Deviation | ng*h/mL | Blood samples collected over a 48 hour period. |
|
|
|
|
| Primary | Cmax of Hydroclorothiazide(Maximum Observed Concentration of Drug Substance in Plasma) | Bioequivalence based on Hydrochlorothiazide Cmax. | All participants that completed the study had their samples analyzed. | Posted | Mean | Standard Deviation | ng/mL | Blood samples collected over a 48 hour period. |
|
|
|
|
| Primary | AUC0-t of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) | Bioequivalence based on Hydrochlorothiazide AUC0-t. | All participants that completed the study had their samples analyzed. | Posted | Mean | Standard Deviation | ng*h/mL | Blood samples collected over a 48 hour period. |
|
|
|
|
| Primary | AUC0-inf of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Infinity) | Bioequivalence based on Hydrochlorothiazide AUC0-inf. | All participants that completed the study had their samples analyzed. | Posted | Mean | Standard Deviation | ng*h/mL | Blood samples collected over a 48 hour period. |
|
|
|
|
| Secondary | Cmax of Losartan Carboxy Acid(Maximum Observed Concentration of Drug Substance in Plasma) | Informational comparison of Cmax values for the metabolite Losartan Carboxy Acid. | All participants that completed the study had their samples analyzed. | Posted | Mean | Standard Deviation | ng/mL | Blood samples collected over a 48 hour period. |
|
|
|
|
| Secondary | AUC0-t of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) | Informational comparison of AUC0-t values for the metabolite Losartan Carboxy Acid. | All participants that completed the study had their samples analyzed. | Posted | Mean | Standard Deviation | ng*h/mL | Blood samples collected over a 48 hour period. |
|
|
|
|
| Secondary | AUC0-inf of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Infinity) | Informational comparison of AUC0-inf values for the metabolite Losartan Carboxy Acid. | All participants that completed the study had their samples analyzed. | Posted | Mean | Standard Deviation | ng*h/mL | Blood samples collected over a 48 hour period. |
|
|
|
|
| 0 |
| 20 |
| 3 |
| 20 |
| EG001 | Hyzaar® (Reference) | 100/25 mg Hyzaar® Tablets reference product dosed in either period. | 0 | 20 | 6 | 20 |
| Pharyngitis | General disorders | MedDRA | Non-systematic Assessment |
|
| Dizziness | General disorders | MedDRA | Non-systematic Assessment |
|
| Sweaty | General disorders | MedDRA | Non-systematic Assessment |
|
| Purpura | General disorders | MedDRA | Non-systematic Assessment |
|
| Leg Muscles Tight | General disorders | MedDRA | Non-systematic Assessment |
|
| Cut Forearm | General disorders | MedDRA | Non-systematic Assessment |
|
| Fell | General disorders | MedDRA | Non-systematic Assessment |
|
| Confussion | General disorders | MedDRA | Non-systematic Assessment |
|
The Principal Investigator is not permitted to discuss or publish trial results.
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |