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

• Status: Completed
• Trial end date: 2019-06-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pharmtechnology LLC
• Collaborators: Altasciences Company Inc.; Altasciences Company, Inc.
• Treatments: Olmesartan; Olmesartan Medoxomil

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