Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Fasting Conditions

• Sponsor: Teva Pharmaceuticals USA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01149486
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 1
• Patients Per Site Per Month: 19.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Losartan potassium/Hydrochlorothiazide; Drug: Hyzaar®	Phase 1

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: A Relative Bioavailability Study of 100/25 mg Losartan Potassium/Hydrochlorothiazide Tablets Under Fasting Conditions
• Study Start Date: Jan 1, 2004
• Actual Primary Completion Date: Feb 1, 2004
• Actual Study Completion Date: Feb 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Generic Test Product Losartan potassium/Hydrochlorothiazide 100/25 mg Tablets	Drug: Losartan potassium/Hydrochlorothiazide; 100/25 mg Tablets
Active Comparator: Reference Listed Drug Hyzaar® 100/25 mg Tablets	Drug: Hyzaar®; 100/25 mg Tablets; Other Names: Losartan potassium/Hydrochlorothiazide (generic name)

Outcome Measures

Primary Outcome Measures

1. Cmax of Losartan(Maximum Observed Concentration of Drug Substance in Plasma) [Blood samples collected over a 48 hour period.]

   Bioequivalence based on Losartan Cmax.

2. AUC0-t of Losartan(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) [Blood samples collected over a 48 hour period.]

   Bioequivalence based on Losartan AUC0-t.

3. AUC0-inf of Losartan(Area Under the Concentration-time Curve From Time Zero to Infinity) [Blood samples collected over a 48 hour period.]

   Bioequivalence based on Losartan AUC0-inf.

4. Cmax of Hydroclorothiazide(Maximum Observed Concentration of Drug Substance in Plasma) [Blood samples collected over a 48 hour period.]

   Bioequivalence based on Hydrochlorothiazide Cmax.

5. AUC0-t of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) [Blood samples collected over a 48 hour period.]

   Bioequivalence based on Hydrochlorothiazide AUC0-t.

6. AUC0-inf of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Infinity) [Blood samples collected over a 48 hour period.]

   Bioequivalence based on Hydrochlorothiazide AUC0-inf.

Secondary Outcome Measures

1. Cmax of Losartan Carboxy Acid(Maximum Observed Concentration of Drug Substance in Plasma) [Blood samples collected over a 48 hour period.]

   Informational comparison of Cmax values for the metabolite Losartan Carboxy Acid.

2. AUC0-t of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) [Blood samples collected over a 48 hour period.]

   Informational comparison of AUC0-t values for the metabolite Losartan Carboxy Acid.

3. AUC0-inf of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Infinity) [Blood samples collected over a 48 hour period.]

   Informational comparison of AUC0-inf values for the metabolite Losartan Carboxy Acid.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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:

• of child bearing potential, is practicing an acceptable barrier method of birth control for the duration of the study

• is postmenopausal for at least 1 year

• is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)

Exclusion Criteria:

• Subjects with a recent history of drug or alcohol abuse or addiction.

• Subjects with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators).

• Subjects whose clinical laboratory test values the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.

• Subjects demonstrating a positive hepatitis B surface antigen screen, a positive hepatitis C antibody screen, or a reactive HIV antibody screen.

• Subjects demonstrating a positive drug abuse screen when screened for the study.

• Female subjects demonstrating a positive pregnancy screen.

• Female subjects who are currently breastfeeding.

• Subjects who have used implanted or injected hormonal contraceptives anytime during the 180 days prior to study dosing or hormonal contraceptives within 14 days of dosing will not be allowed to participate.

• Subjects with a history of allergic response(s) to losartan, hydrochlorothiazide or related drugs.

• Subjects with a history of clinically significant allergies including drug allergies.

• Subjects with a clinically significant illness during the 4 weeks prior to dosing (as determined by the clinical investigators).

• Subjects who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to dosing.

• Subjects who have used tobacco products within 90 days of Period 1 dose administration.

• Subjects who report donating greater than 150 mL of blood within 14 days prior to dosing.

• Subjects who report receiving any investigational drug within 28 days prior to dosing.

• Subjects who report taking any systemic prescription medication in the 14 days prior to dosing.

• Subjects who report an intolerance of direct venipuncture.

• Subjects who report consuming an abnormal diet within the 28 days prior to dosing.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PRACS Institute, Ltd.	Fargo	North Dakota	United States	58104

Sponsors and Collaborators

• Teva Pharmaceuticals USA

Investigators

• Principal Investigator: James D Carlson, Pharm. D., PRACS Institute, Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01149486
• Other Study ID Numbers: R04-080
• First Posted: Jun 23, 2010
• Last Update Posted: Dec 8, 2010
• Last Verified: Nov 1, 2010

• Keywords provided by , ,: Bioequivalence; Healthy Subjects
• Additional relevant MeSH terms: Losartan; Hydrochlorothiazide

Study Results

Participant Flow

Arm/Group Title	Losartan/HCTZ (Test) First	Hyzaar® (Reference) First
Arm/Group Description	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.	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.
Period Title: First Intervention
STARTED	10	10
COMPLETED	10	9
NOT COMPLETED	0	1
Period Title: First Intervention
STARTED	10	9
COMPLETED	10	9
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	10	9
COMPLETED	10	9
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Losartan/HCTZ (Test) First	Hyzaar® (Reference) First	Total
Arm/Group Description	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.	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.	Total of all reporting groups
Overall Participants	10	10	20
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	10 100%	10 100%	20 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	2 20%	1 10%	3 15%
Male	8 80%	9 90%	17 85%
Race/Ethnicity, Customized (participants) [Number]
American Indian	1 10%	1 10%	2 10%
Black	0 0%	1 10%	1 5%
Caucasian	9 90%	8 80%	17 85%
Region of Enrollment (participants) [Number]
United States	10 100%	10 100%	20 100%

Outcome Measures

1. Primary Outcome

Title	Cmax of Losartan(Maximum Observed Concentration of Drug Substance in Plasma)
Description	Bioequivalence based on Losartan Cmax.
Time Frame	Blood samples collected over a 48 hour period.

Outcome Measure Data

Analysis Population Description

All participants that completed the study had their samples analyzed.

Arm/Group Title	Losartan/HCTZ (Test)	Hyzaar® (Reference)
Arm/Group Description	100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.	100/25 mg Hyzaar® Tablets reference product dosed in either period.
Measure Participants	19	19
Mean (Standard Deviation) [ng/mL]	509.63 (314.75)	538.11 (298.89)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Losartan/HCTZ (Test), Hyzaar® (Reference)
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of the T/R geometric mean x 100
	Estimated Value	93.45
	Confidence Interval	(2-Sided) 90%; 80.20 to 108.88
	Parameter Dispersion	Type: Value:
	Estimation Comments	Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.

2. Primary Outcome

Title	AUC0-t of Losartan(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Description	Bioequivalence based on Losartan AUC0-t.
Time Frame	Blood samples collected over a 48 hour period.

Outcome Measure Data

Analysis Population Description

All participants that completed the study had their samples analyzed.

Arm/Group Title	Losartan/HCTZ (Test)	Hyzaar® (Reference)
Arm/Group Description	100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.	100/25 mg Hyzaar® Tablets reference product dosed in either period.
Measure Participants	19	19
Mean (Standard Deviation) [ng*h/mL]	866.88 (366.15)	865.00 (362.86)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Losartan/HCTZ (Test), Hyzaar® (Reference)
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of the T/R geometric mean x 100
	Estimated Value	99.45
	Confidence Interval	(2-Sided) 90%; 93.15 to 106.18
	Parameter Dispersion	Type: Value:
	Estimation Comments	Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.

3. Primary Outcome

Title	AUC0-inf of Losartan(Area Under the Concentration-time Curve From Time Zero to Infinity)
Description	Bioequivalence based on Losartan AUC0-inf.
Time Frame	Blood samples collected over a 48 hour period.

Outcome Measure Data

Analysis Population Description

All participants that completed the study had their samples analyzed.

Arm/Group Title	Losartan/HCTZ (Test)	Hyzaar® (Reference)
Arm/Group Description	100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.	100/25 mg Hyzaar® Tablets reference product dosed in either period.
Measure Participants	19	19
Mean (Standard Deviation) [ng*h/mL]	880.15 (368.58)	877.99 (362.75)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Losartan/HCTZ (Test), Hyzaar® (Reference)
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of the T/R geometric mean x 100
	Estimated Value	99.4
	Confidence Interval	(2-Sided) 90%; 93.10 to 106.12
	Parameter Dispersion	Type: Value:
	Estimation Comments	Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.

4. Primary Outcome

Title	Cmax of Hydroclorothiazide(Maximum Observed Concentration of Drug Substance in Plasma)
Description	Bioequivalence based on Hydrochlorothiazide Cmax.
Time Frame	Blood samples collected over a 48 hour period.

Outcome Measure Data

Analysis Population Description

All participants that completed the study had their samples analyzed.

Arm/Group Title	Losartan/HCTZ (Test)	Hyzaar® (Reference)
Arm/Group Description	100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.	100/25 mg Hyzaar® Tablets reference product dosed in either period.
Measure Participants	19	19
Mean (Standard Deviation) [ng/mL]	177.63 (48.09)	161.56 (53.75)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Losartan/HCTZ (Test), Hyzaar® (Reference)
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of the T/R geometric mean x 100
	Estimated Value	111.62
	Confidence Interval	(2-Sided) 90%; 101.47 to 122.79
	Parameter Dispersion	Type: Value:
	Estimation Comments	Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.

5. Primary Outcome

Title	AUC0-t of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Description	Bioequivalence based on Hydrochlorothiazide AUC0-t.
Time Frame	Blood samples collected over a 48 hour period.

Outcome Measure Data

Analysis Population Description

All participants that completed the study had their samples analyzed.

Arm/Group Title	Losartan/HCTZ (Test)	Hyzaar® (Reference)
Arm/Group Description	100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.	100/25 mg Hyzaar® Tablets reference product dosed in either period.
Measure Participants	19	19
Mean (Standard Deviation) [ng*h/mL]	1057.58 (231.26)	1001.54 (236.00)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Losartan/HCTZ (Test), Hyzaar® (Reference)
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of the T/R geometric mean x 100
	Estimated Value	105.8
	Confidence Interval	(2-Sided) 90%; 99.58 to 112.41
	Parameter Dispersion	Type: Value:
	Estimation Comments	Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.

6. Primary Outcome

Title	AUC0-inf of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Infinity)
Description	Bioequivalence based on Hydrochlorothiazide AUC0-inf.
Time Frame	Blood samples collected over a 48 hour period.

Outcome Measure Data

Analysis Population Description

All participants that completed the study had their samples analyzed.

Arm/Group Title	Losartan/HCTZ (Test)	Hyzaar® (Reference)
Arm/Group Description	100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.	100/25 mg Hyzaar® Tablets reference product dosed in either period.
Measure Participants	19	19
Mean (Standard Deviation) [ng*h/mL]	1087.64 (240.82)	1030.73 (238.96)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Losartan/HCTZ (Test), Hyzaar® (Reference)
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of the T/R geometric mean x 100
	Estimated Value	105.55
	Confidence Interval	(2-Sided) 90%; 99.64 to 111.82
	Parameter Dispersion	Type: Value:
	Estimation Comments	Bioequivalence is established if the 90% confidence interval for the ln-transformed geometric mean between the reference (R) and test (T) product fall within the interval of 80-125%.

7. Secondary Outcome

Title	Cmax of Losartan Carboxy Acid(Maximum Observed Concentration of Drug Substance in Plasma)
Description	Informational comparison of Cmax values for the metabolite Losartan Carboxy Acid.
Time Frame	Blood samples collected over a 48 hour period.

Outcome Measure Data

Analysis Population Description

All participants that completed the study had their samples analyzed.

Arm/Group Title	Losartan/HCTZ (Test)	Hyzaar® (Reference)
Arm/Group Description	100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.	100/25 mg Hyzaar® Tablets reference product dosed in either period.
Measure Participants	19	19
Mean (Standard Deviation) [ng/mL]	726.85 (210.78)	675.54 (197.25)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Losartan/HCTZ (Test), Hyzaar® (Reference)
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of the T/R geometric mean x 100
	Estimated Value	106.78
	Confidence Interval	(2-Sided) 90%; 98.96 to 115.23
	Parameter Dispersion	Type: Value:
	Estimation Comments	This analysis was for informational purposes only and was not used to establish bioequivalence.

8. Secondary Outcome

Title	AUC0-t of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Description	Informational comparison of AUC0-t values for the metabolite Losartan Carboxy Acid.
Time Frame	Blood samples collected over a 48 hour period.

Outcome Measure Data

Analysis Population Description

All participants that completed the study had their samples analyzed.

Arm/Group Title	Losartan/HCTZ (Test)	Hyzaar® (Reference)
Arm/Group Description	100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.	100/25 mg Hyzaar® Tablets reference product dosed in either period.
Measure Participants	19	19
Mean (Standard Deviation) [ng*h/mL]	4236.78 (1176.34)	4117.07 (1087.67)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Losartan/HCTZ (Test), Hyzaar® (Reference)
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of the T/R geometric mean x 100
	Estimated Value	102.37
	Confidence Interval	(2-Sided) 90%; 98.75 to 106.14
	Parameter Dispersion	Type: Value:
	Estimation Comments	This analysis was for informational purposes only and was not used to establish bioequivalence.

9. Secondary Outcome

Title	AUC0-inf of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Infinity)
Description	Informational comparison of AUC0-inf values for the metabolite Losartan Carboxy Acid.
Time Frame	Blood samples collected over a 48 hour period.

Outcome Measure Data

Analysis Population Description

All participants that completed the study had their samples analyzed.

Arm/Group Title	Losartan/HCTZ (Test)	Hyzaar® (Reference)
Arm/Group Description	100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.	100/25 mg Hyzaar® Tablets reference product dosed in either period.
Measure Participants	19	19
Mean (Standard Deviation) [ng*h/mL]	4281.32 (1182.77)	4164.62 (1096.64)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Losartan/HCTZ (Test), Hyzaar® (Reference)
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	ANOVA is to be used to identify the source contributions by factors including subjects, period, formulation and potential interactions. The geometric mean ratio together with the ANOVA residual mean error term are used to identify the statistical basis for the 90% confidence interval for the ratio of the population means (Test [T]/Reference[R]) of the identified metrics (e.g. AUC, Cmax).
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Ratio of the T/R geometric mean x 100
	Estimated Value	102.3
	Confidence Interval	(2-Sided) 90%; 98.72 to 106.01
	Parameter Dispersion	Type: Value:
	Estimation Comments	This analysis was for informational purposes only and was not used to establish bioequivalence.

Adverse Events

Time Frame	Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration.
Adverse Event Reporting Description	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.
Arm/Group Title	Losartan/HCTZ (Test)		Hyzaar® (Reference)
Arm/Group Description	100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.		100/25 mg Hyzaar® Tablets reference product dosed in either period.
All Cause Mortality
	Losartan/HCTZ (Test)		Hyzaar® (Reference)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Losartan/HCTZ (Test)		Hyzaar® (Reference)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Losartan/HCTZ (Test)		Hyzaar® (Reference)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/20 (15%)		6/20 (30%)
General disorders
Headache	3/20 (15%)	3	3/20 (15%)	3
Pharyngitis	0/20 (0%)	0	1/20 (5%)	1
Dizziness	1/20 (5%)	1	1/20 (5%)	2
Sweaty	1/20 (5%)	1	0/20 (0%)	0
Purpura	1/20 (5%)	1	0/20 (0%)	0
Leg Muscles Tight	0/20 (0%)	0	1/20 (5%)	1
Cut Forearm	0/20 (0%)	0	1/20 (5%)	1
Fell	0/20 (0%)	0	1/20 (5%)	1
Confussion	0/20 (0%)	0	1/20 (5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Principal Investigator is not permitted to discuss or publish trial results.