A Bioequivalence Study of Losartan Potassium Tablets (Containing Losartan Potassium 100 mg) in Normal, Healthy, Adults Under Fasting Conditions

NCT03459911 | Completed Phase 1

• 1 other identifier: RLS/1117/046
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

To demonstrate bioequivalence of single dose test formulation of Losartan potassium tablets (containing Losartan potassium 100 mg) of Pharmtechnology LLC, Republic of Belarus with reference Cozaar® (containing Losartan potassium 100 mg) of "Merck Sharpe \& Dohme B.V.", Haarlem, the Netherlands in normal, healthy, adult, human subjects under fasting conditions.To monitor adverse events and ensure the safety

Conditions

Healthy

Keywords

Bioequivalence

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic parameter for losartan

  Peak Plasma Concentration (Cmax)

  10 Days

• Pharmacokinetic parameter for losartan

  Area under the plasma concentration versus time curve from time 0 to the last measured concentration (AUC0-t)

  10 Days

Secondary Outcomes (6)

• Safety and tolerability of investigational products

  17 Days

• Other pharmacokinetic parameters for losartan

  10 Days

• Other pharmacokinetic parameters for losartan

  10 Days

• Other pharmacokinetic parameters for losartan

  10 Days

• Other pharmacokinetic parameters for losartan

  10 Days

Study Arms (2)

Losartan potassium 100 mg Tablets

EXPERIMENTAL

Losartan potassium is the test product. In period 1 and period 2, 33 of 66 subjects will be given single oral dose (1 x 100 mg) of Losartan potassium.

Drug: Losartan potassium 100mg

Cozaar® (Losartan potassium)100 mg Tablets

ACTIVE COMPARATOR

Cozaar® (Losartan potassium) is the reference product. In period 1 and period 2, 33 of 66 subjects will be given single oral dose (1 x 100 mg) of Cozaar®.

Drug: Cozaar 100mg Tablet

Interventions

Cozaar 100mg Tablet DRUG

Cozaar® ( Losartan potassium) 100 mg Tablets(Merck Sharpe \& Dohme B.V. , Haarlem, the Netherlands)

Cozaar® (Losartan potassium)100 mg Tablets

Losartan potassium 100mg DRUG

Losartan potassium 100 mg Tablets ( Pharmtechnology LLC, Republic of Belarus)

Losartan potassium 100 mg Tablets

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The following criteria should be checked at the time of study entry. If any does not apply at the time of study entry, the subject must not be included in the study:
• Healthy adult human subjects, aged between 18 to 45 years (both inclusive).
• Subjects with Body Mass Index (BMI) 18.5 to 24.9 kg/m2
• Subjects able and willing to comply with the protocol requirements.
• Subjects should not have any medical history of significant diseases.
• If subject is a female and is
• of child bearing potential, she should be practicing an acceptable method of birth control for the duration of the study as suggested by the investigator, such as a combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier method), intrauterine device (IUD), or abstinence.
• surgically sterile, bilateral tubal ligation done at least 6 months before the study should be documented.
• Subjects willing to voluntarily provide written informed consent.
• Subjects willing to undergo pre- and post-study physical examinations and laboratory investigations.
• Subjects who are non-smokers based on history.
• Subjects willing to adhere to the protocol and the following study requirements:
• Should not consume xanthine containing products, such as coffee, tea, chocolate or soft drinks at least 48 hours prior to dosing (i.e. in-house monitoring and the remaining based on history) until the last sample collection.
• Should not consume alcohol at least 48 hours prior to dosing (i.e. during in-house monitoring and the remaining based on history) until the last sample collection.
• Should not consume grapefruit or its products at least 7 days prior to each dosing (i.e. during in-house monitoring and the remaining based on history) and until the last sample collection.

You may not qualify if:

• The following criteria should be checked at the time of study entry. If any of these apply at the time of study entry, the subject must not be included in the study:
• Subjects incapable of understanding the informed consent process.
• Female subjects with a positive pregnancy test at screening or positive serum β-HCG test (done at check-in of each study periods) or lactating females.
• Subjects with inadequate venous access in their left or right arm to allow the collection of all samples via venous cannula in the study.
• Subjects with abnormalities in resting heart rate (\>100 beats/min or \<50 beats/min), blood pressure either hypotensive episode (systolic blood pressure \<90 mmHg or diastolic blood pressure \<60 mmHg) or hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥90 mmHg), oral temperature (\< 95.60F or \> 990F) on the screening day.
• Subjects with history of psychiatric disorders, which are likely to limit the validity of consent to participate in the study, or limit the ability to comply with the protocol requirements.
• Subjects with any evidence of organ dysfunction or any clinically significant deviation from normal in their physical or clinical evaluation including ECG and X-ray results.
• Subjects who have taken over the counter or prescribed medications, including any enzyme modifying drugs or any systemic medication within 30 days prior to the start of the clinical period and during the study period.
• Subjects with a known history of drug hypersensitivity to losartan or any excipients of the formulation.
• Subjects with a history of alcohol abuse and/or drug abuse or who are found urinary screen test positive for drugs of abuse (Amphetamines, Morphine, Benzodiazepines, Marijuana, Cocaine and Barbiturates) or are found with current alcohol abuse based on alcohol breath test.
• Subjects diagnosed to be HIV 1 and 2 or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus positive.
• Subjects with clinically significant abnormal haematological values \[haemoglobin (Hb), total white blood cells count (WBC), total red blood cells count (RBC), differential WBC count, platelet count and hematocrit\].
• Subjects with clinically significant abnormal laboratory values for serum creatinine, blood urea nitrogen (BUN), serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase (ALP), serum bilirubin, serum glucose (fasting), and serum cholesterol.
• Subjects with clinically significant abnormal urine analysis, defined as the presence of RBC (\>5/HPF), pus cells (\>5/HPF), epithelial cells (\>5/HPF), glucose (positive), ketones (positive), bilirubin (positive) and protein (positive) (unless the clinical investigator considers the deviation to be irrelevant for the purpose of the study).
• Subjects with a clinically significant past history or current medical condition of:

Sponsors & Collaborators

• Pharmtechnology LLC: lead
• Reliance Life Sciences Private Limited: collaborator

Study Sites (1)

Clinical Unit, Reliance Life Sciences Pvt. Ltd.

Mumbai, Maharashtra, 400 701, India

Location

MeSH Terms

Interventions

Losartan; Tablets

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Suresh A Maroli, MD

  Reliance Life Sciences Pvt. Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study is an open label study; the subjects and the investigator will not be blinded towards the identity of the investigational products. However, analysts will be blinded towards identity of investigational product administered.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 9, 2018
• Study Start: February 16, 2018
• Primary Completion: March 11, 2018
• Study Completion: March 16, 2018
• Last Updated: November 2, 2018

Record last verified: 2018-06

Locations

IN (1)