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The Bioequivalence Study of Two Different Formulations of Olmesartan Medoxomil After a Single Oral Dose Administration Under Fasting Conditions.

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ClinicalTrials.gov Identifier: NCT03951051
Recruitment Status : Completed
First Posted : May 15, 2019
Last Update Posted : July 29, 2019
Sponsor:
Collaborator:
Altasciences Company Inc.
Information provided by (Responsible Party):
Pharmtechnology LLC

Brief Summary:
This single dose study is designed in accordance with EMA (the European Medicines Agency) regulatory guidelines, with the aim of characterizing the bioavailability of olmesartan in the two formulations in healthy subjects. As this is a bioequivalence trial where each subject will receive each study treatment in a crossover fashion, a control group is not included. Within the clinical portion of the study each subject will receive a single oral dose of the test and the reference formulation in compliance with the generated randomization code. The primary study endpoints are the pharmacokinetic (PK) parameters Cmax and AUC0-t of olmesartan.

Condition or disease Intervention/treatment Phase
Bioequivalence Drug: Olmesartan Medoxomil 40 mg Drug: Olmetec® Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The randomization code will not be available to the personnel of the bioanalytical facility until the bioanalytical tables have been finalized and audited by the Quality Assurance (QA) department.
Primary Purpose: Other
Official Title: Single Dose Crossover Comparative Bioavailability Study of Olmesartan Medoxomil 40 mg Film-coated Tablets in Healthy Adult Subjects Under Fasting Conditions.
Actual Study Start Date : May 6, 2019
Actual Primary Completion Date : June 16, 2019
Actual Study Completion Date : June 16, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sequence AB
16 subjects assigned to the sequence AB will receive a single 40 mg dose of the test product Olmesartan Medoxomil (1 x 40 mg film-coated tablet), marked as A in the sequence, in Period 1 and a single 40 mg dose of the reference product Olmetec® (1 x 40 mg film-coated tablet), marked as B in the sequence, in period 2. These treatments will be administered orally with approximately 240 mL of water at ambient temperature, in the morning, following a minimum of 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken.
Drug: Olmesartan Medoxomil 40 mg
Olmesartan Medoxomil is manufactured by Pharmtechnology LLC, Republic of Belarus. Each film-coated tablet contains 40 mg of olmesartan medoxomil.
Other Name: the test product

Drug: Olmetec®
Olmetec® is manufactured by Daiichi Sankyo Europe GmbH, Germany. Each film-coated tablet contains 40 mg of olmesartan medoxomil.
Other Name: the reference product

Sequence BA
16 subjects assigned to the sequence BA will receive a single 40 mg dose of the reference product Olmetec® (1 x 40 mg film-coated tablet), marked as B in the sequence, in Period 1 and a single 40 mg dose of the test product Olmesartan Medoxomil (1 x 40 mg film-coated tablet), marked as A in the sequence, in period 2. These treatments will be administered orally with approximately 240 mL of water at ambient temperature, in the morning, following a minimum of 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken.
Drug: Olmesartan Medoxomil 40 mg
Olmesartan Medoxomil is manufactured by Pharmtechnology LLC, Republic of Belarus. Each film-coated tablet contains 40 mg of olmesartan medoxomil.
Other Name: the test product

Drug: Olmetec®
Olmetec® is manufactured by Daiichi Sankyo Europe GmbH, Germany. Each film-coated tablet contains 40 mg of olmesartan medoxomil.
Other Name: the reference product




Primary Outcome Measures :
  1. Cmax of olmesartan in plasma after administration of the test and the reference products [ Time Frame: Time points 0.00 (prior to each drug administration) and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00 hours after each drug administration ]
    Maximum observed concentration in plasma

  2. AUC0-t of olmesartan in plasma after administration of the test and the reference products [ Time Frame: Time points 0.00 (prior to each drug administration) and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00 hours after each drug administration ]
    Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration (TLQC) using the linear trapezoidal method


Secondary Outcome Measures :
  1. Tmax of olmesartan in plasma after administration of the test and the reference products [ Time Frame: Time points 0.00 (prior to each drug administration) and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00 hours after each drug administration ]
    Time of maximum observed concentration; if it occurs at more than one time point, Tmax is defined as the first time point with this value

  2. TLQC of olmesartan in plasma after administration of the test and the reference products [ Time Frame: Time points 0.00 (prior to each drug administration) and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00 hours after each drug administration ]
    Time of last observed quantifiable concentration

  3. AUC0-INF of olmesartan in plasma after administration of the test and the reference products [ Time Frame: Time points 0.00 (prior to each drug administration) and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00 hours after each drug administration ]
    Area under the concentration time curve extrapolated to infinity, calculated as AUC0-t + ĈLQC (the predicted concentration at time TLQC) / λZ (apparent elimination rate constant)

  4. Residual area of olmesartan in plasma after administration of the test and the reference products [ Time Frame: Time points 0.00 (prior to each drug administration) and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00 hours after each drug administration ]
    Extrapolated area (i.e. percentage of AUC0-INF due to extrapolation from TLQC to infinity)

  5. Time point where the log-linear elimination phase begins (TLIN) of olmesartan in plasma after administration of the test and the reference products [ Time Frame: Time points 0.00 (prior to each drug administration) and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00 hours after each drug administration ]
    Time point where the log-linear elimination phase begins

  6. λZ of olmesartan in plasma after administration of the test and the reference products [ Time Frame: Time points 0.00 (prior to each drug administration) and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00 hours after each drug administration ]
    Apparent elimination rate constant, estimated by linear regression of the terminal linear portion of the log concentration versus time curve

  7. Terminal elimination half-life (Thalf) of olmesartan in plasma after administration of the test and the reference products [ Time Frame: Time points 0.00 (prior to each drug administration) and 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.33, 2.67, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 12.00, 16.00, 24.00, 36.00, 48.00 hours after each drug administration ]
    Terminal elimination half-life, calculated as ln(2)/λZ

  8. Number of treatment-emergent adverse events for the test and the reference products [ Time Frame: Up to 10 days (after the first drug administration until the completion of clinical part of the study) ]
    The safety population will include all subjects who received at least one dose of the test or the reference product. Any significant changes will be recorded as treatment-emergent adverse events only if they are judged clinically significant by the qualified investigator or delegate.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

1. Provision of signed and dated informed consent form (ICF) 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Healthy male or female adult volunteer 4. A female volunteer meeting one of the following criteria:

  1. Physiological postmenopausal status, defined as the following:

    1. absence of menses for at least one year prior to the first study drug administration (without an alternative medical condition); and
    2. Follicle stimulating hormone (FSH) levels ≥ 40 mIU/mL at screening;

    or

  2. Surgical postmenopausal status, defined as the following:

    1. bilateral oophorectomy; and
    2. absence of menses for at least 90 days prior to the first study drug administration; and
    3. FSH levels ≥ 40 mIU/mL at screening;

    or

  3. Hysterectomy with FSH levels ≥ 40 mIU/mL at screening If the postmenopausal volunteer has an FSH of < 40 mIU/mL, but meets the above criteria in either (1), (2) or (3) and all the other inclusion criteria, the volunteer may be included in the study if the estradiol serum level measured at screening is equal to or below 150 pmol/L. In the case of hysterectomy, if FSH and estradiol do not meet the criteria, inclusion of the volunteer will be based on medical judgment.

5. Volunteer aged at least 18 years but not older than 55 years 6. Volunteer with a body mass index (BMI) within 18.5 kg/m2 to 30.0 kg/m2, inclusively 7. Light-, non- or ex-smoker. A light smoker is defined as someone using 10.0 nicotine units or less per day for at least 90 days prior to the first study drug administration. An ex-smoker is defined as someone who completely stopped using nicotine products for at least 180 days prior to the first study drug administration 8. Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without clinical significance, as determined by an investigator 9. Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including vital signs) and/or ECG, as determined by an investigator

Exclusion Criteria:

  1. Females who are lactating at screening
  2. Females who are pregnant according to the pregnancy test at screening
  3. Seated pulse rate less than 50 Beats per Minute (bpm) or more than 100 bpm at the screening visit or prior to the first study drug administration
  4. Seated blood pressure below 110/60 mmHg at the screening visit or prior to the first study drug administration
  5. History of significant hypersensitivity to olmesartan or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs
  6. Presence of significant gastrointestinal, liver or kidney disease, or any other condition known to interfere with drug absorption, distribution, metabolism or excretion, or known to potentiate or predispose to undesired effects
  7. History of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability, including but not limited to cholecystectomy
  8. History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
  9. Presence of clinically significant ECG abnormalities at the screening visit, as defined by medical judgment
  10. History of rare hereditary problems of galactose and/or lactose intolerance, lactase deficiency or glucose-galactose malabsorption
  11. Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)
  12. Any clinically significant illness in the 28 days prior to the first study drug administration
  13. Use of any prescription drugs (with the exception of hormone replacement therapy) in the 28 days prior to the first study drug administration, that in the opinion of an investigator would put into question the status of the volunteer as healthy
  14. Any history of tuberculosis
  15. Positive test result for alcohol and/or drugs of abuse at screening or prior to the first drug administration
  16. Positive screening results to HIV Ag/Ab Combo, Hepatitis B surface Antigen or Hepatitis C Virus tests
  17. Volunteers who have already been included in a previous group for this clinical study
  18. Volunteers who took olmesartan in the 28 days prior to the first study drug administration
  19. Volunteers who took an Investigational Product (IP) in the 28 days prior to the first study drug administration
  20. Volunteers who donated 50 mL or more of blood in the 28 days prior to the first study drug administration
  21. Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the 56 days prior to the first study drug administration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951051


Locations
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Canada, Quebec
Altasciences Company Inc.
Mont-Royal, Quebec, Canada, H3P 3P1
Sponsors and Collaborators
Pharmtechnology LLC
Altasciences Company Inc.
Investigators
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Principal Investigator: Eric Sicard, MD Altasciences Company Inc.

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Responsible Party: Pharmtechnology LLC
ClinicalTrials.gov Identifier: NCT03951051     History of Changes
Other Study ID Numbers: PTL-P1-627 (v. 2.0 05/14/2019)
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: July 29, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pharmtechnology LLC:
Olmesartan Medoxomil
Bioequivalence
Olmetec
Additional relevant MeSH terms:
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Olmesartan
Olmesartan Medoxomil
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action