Bioequivalency Study of Losartan Potassium/Hydrochlorothiazide 100 mg/25 mg Tablet Under Fasted Conditions

• ClinicalTrials.gov Identifier: NCT01102478
• Recruitment Status: Completed
• First Posted: April 13, 2010
• Last Update Posted: January 23, 2018
• Sponsor: Roxane Laboratories
• Information provided by: West-Ward Pharmaceutical

Tracking Information

• First Submitted Date: April 9, 2010
• First Posted Date: April 13, 2010
• Last Update Posted Date: January 23, 2018
• Study Start Date: February 2005
• Actual Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 12, 2010): Bioequivalence determined by statistical comparison Cmax [ Time Frame: 25 days ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01102478 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Bioequivalency Study of Losartan Potassium/Hydrochlorothiazide 100 mg/25 mg Tablet Under Fasted Conditions
• Official Title: A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Losartan Potassium/Hydrochlorothiazide Tablets 100 mg/25 mg Under Fasting Conditions
• Brief Summary: The objective of this study was to prove the bioequivalence of Losartan Potassium/Hydrochlorothiazide 100/25 mg tablet under fasted conditions.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hypertension

Intervention

Drug: losartan potassium / hydrochlorothiazide

100 mg / 25 mg tablet

Other Name: Hyzaar

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 12, 2010): 30
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: March 2005
• Actual Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

• Positive test for HIV, Hepatitis B, or Hepatitis C.
• Treatment with known enzyme altering drugs.
• History of allergic or adverse response to losartan potassium hydrochlorothiazide or any comparable or similar product.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01102478
• Other Study ID Numbers: LOHY-T100/25-PVFS-1
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Elizabeth Ernst, Roxane Laboratories, Inc.
• Study Sponsor: Roxane Laboratories
• Collaborators: Not Provided

Investigators

• Principal Investigator: Daniel V Freeland, D.O.; CEDRA Clinical Research, LLC

• PRS Account: West-Ward Pharmaceutical
• Verification Date: January 2018