Healthy Clinical Trial
Official title:
A Randomized, Open-label, Single-dose, Two-treatment, Two-sequence, Two-period, Crossover Bioequivalence Study of Test 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
Verified date | June 2018 |
Source | Pharmtechnology LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 66 |
Est. completion date | March 16, 2018 |
Est. primary completion date | March 11, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: 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: 1. Healthy adult human subjects, aged between 18 to 45 years (both inclusive). 2. Subjects with Body Mass Index (BMI) 18.5 to 24.9 kg/m2 3. Subjects able and willing to comply with the protocol requirements. 4. Subjects should not have any medical history of significant diseases. 5. 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. OR - surgically sterile, bilateral tubal ligation done at least 6 months before the study should be documented. 6. Subjects willing to voluntarily provide written informed consent. 7. Subjects willing to undergo pre- and post-study physical examinations and laboratory investigations. 8. Subjects who are non-smokers based on history. 9. 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. 10. Subjects having no clinically significant medical history and no clinically significant abnormalities in general physical examination, laboratory assessments, 12-lead ECG, chest X-Ray or vital signs. Exclusion Criteria: 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: 1. Subjects incapable of understanding the informed consent process. 2. Female subjects with a positive pregnancy test at screening or positive serum ß-HCG test (done at check-in of each study periods) or lactating females. 3. Female subjects of childbearing potential who are unwilling or unable to use an appropriate method of contraception as outlined in the inclusion criteria, at least 28 days prior to the first period dosing until the post-study follow-up (i.e. until 7 days from the drug administration in Period II). Use of hormonal contraceptives either oral or implants within 3 months prior to first period dosing will not be acceptable. 4. Subjects with inadequate venous access in their left or right arm to allow the collection of all samples via venous cannula in the study. 5. 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. 6. 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. 7. 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. 8. 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. 9. Subjects with a known history of drug hypersensitivity to losartan or any excipients of the formulation. 10. 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. 11. Subjects diagnosed to be HIV 1 and 2 or Hepatitis B (HBsAg) or Hepatitis C (HCV) virus positive. 12. 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]. 13. 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. 14. 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). 15. Subjects with a clinically significant past history or current medical condition of: 1. Pulmonary disorders (COPD and asthma) 2. Cardiovascular disorders (especially heart blocks, myocardial infarction, congestive heart failure and uncontrolled hypertension) 3. Neurological disorders (especially epileptic seizures) 4. GIT disorders (gastrointestinal bleeding, gastric/peptic ulcer) 5. Renal and/or hepatic disorders 6. Coagulation disorders 7. Endocrine disorders (especially diabetes mellitus) 16. Any history of difficulty in donating blood 17. Any clinically significant illness during 3 months before screening. 18. Subjects who participated in any other clinical investigation using experimental drugs or have bled more than 300 mL in the past 3 months |
Country | Name | City | State |
---|---|---|---|
India | Clinical Unit, Reliance Life Sciences Pvt. Ltd. | Mumbai | Maharashtra |
Lead Sponsor | Collaborator |
---|---|
Pharmtechnology LLC | Reliance Life Sciences Private Limited |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pharmacokinetic parameter for losartan | Peak Plasma Concentration (Cmax) | 10 Days | |
Primary | 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 | Safety and tolerability of investigational products | Number of adverse events, number of deaths, number of severe adverse events in subjects who have taken at least one dose of investigational products. | 17 Days | |
Secondary | Other pharmacokinetic parameters for losartan | Area under the plasma concentration versus time curve from time 0 to to infinite time(AUC0-8) | 10 Days | |
Secondary | Other pharmacokinetic parameters for losartan | Time of maximum measured plasma concentration (Tmax) | 10 Days | |
Secondary | Other pharmacokinetic parameters for losartan | Elimination or terminal half-life (T1/2) | 10 Days | |
Secondary | Other pharmacokinetic parameters for losartan | Elimination rate constant (Kel) | 10 Days | |
Secondary | Other pharmacokinetic parameters for losartan | Residual area (AUCresid) | 10 Days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |