A Bioequivalence Study of Two Different Formulations of Olmesartan Medoxomil/ Hydrochlorothiazide After a Single Oral Dose Administration Under Fasting Conditions

• Status: Unknown status
• Trial end date: 2019-12-24
• Target enrollment: 0
• Participant gender: All

Summary

This single dose study was designed in accordance with EMA (the European Medicines Agency) regulatory guidelines, with the aim of characterizing the bioavailability of olmesartan medoxomil/ hydrochlorothiazide in the two formulations (Olmesartan Medoxomil/ Hydrochlorothiazide (HCTZ), 40 mg/ 25 mg film-coated tablets (Manufacturer: Pharmtechnology LLC, Republic of Belarus) and Olmetec Plus® (Olmesartan Medoxomil/ Hydrochlorothiazide), 40 mg/25 mg film-coated tablets, (Manufacturer: Daiichi Sankyo Europe GmbH, Germany)) in healthy subjects. As this is a bioequivalence trial where each subject received each study treatment in a crossover fashion, a control group was not included. Within the clinical portion of the study each subject received a single oral dose of the test and the reference formulation in compliance with the generated randomization code. The primary study endpoints were the pharmacokinetic (PK) parameters Cmax and AUC0-t of olmesartan and hydrochlorothiazide.

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

Details

• Lead Sponsor: Pharmtechnology LLC
• Collaborators: Altasciences Company Inc.; Altasciences Company, Inc.
• Treatments: Hydrochlorothiazide; 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 Caucasian adult male or female;

4. If female, meets one of the following criteria:

A. 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

B. 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 C. Hysterectomy with FSH levels ≥ 40 mIU/mL at screening. If the postmenopausal subject has an FSH of < 40 mIU/mL, but meets the above criteria in either (A), (B) or (C) and all the other inclusion criteria, the subject may be included in the study if the estradiol serum level measured at screening is equal to or below 150 pmol/L;

5. Aged at least 18 years but not older than 50 years;

6. Body mass index (BMI) within 18.50 kg/m2 to 30.00 kg/m2, inclusively;

7. Non- or ex smoker (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 (CS) diseases captured in the medical history or evidence of CS findings on the physical examination (including vital signs) and/or electrocardiogram (ECG), as determined by an investigator.

Exclusion Criteria:

1. Female who is lactating at screening;

2. Female who is 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 and prior to the first study drug administration;

4. Seated blood pressure below 110/60 mmHg at the screening visit and prior to the first study drug administration;

5. History of significant hypersensitivity to olmesartan and HCTZ or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs;

6. Presence or history of significant gastrointestinal, liver or kidney disease, or any other condition that is known to interfere with drug absorption, distribution, metabolism or excretion, or known to potentiate or predispose to undesired effects;

7. History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease;

8. Presence of CS ECG abnormalities at the screening visit, as defined by medical judgment;

9. History of rare hereditary problems of galactose and/or lactose intolerance, lactase deficiency or glucose-galactose malabsorption;

10. Maintenance therapy with any drug or significant history of drug dependency or alcohol abuse (> 3 units of alcohol per day [1 unit = 10 mL of pure alcohol], intake of excessive alcohol, acute or chronic);

11. Any CS illness in the 28 days prior to the first study drug administration;

12. Use of any prescription drugs (with the exception of hormonal contraceptives or 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 participant as healthy;

13. Any history of tuberculosis;

14. Positive test result for alcohol and/or drugs of abuse at screening or prior to the first drug administration;

15. Positive screening results to HIV Ag/Ab combo, hepatitis B surface antigen or hepatitis C virus tests;

16. Inclusion in a previous group for this clinical study;

17. Intake of olmesartan medoxomil or HCTZ in the 28 days prior to the first study drug administration;

18. Intake of an Investigational Product (IP) in the 28 days prior to the first study drug administration;

19. Donation of 50 mL or more of blood in the 28 days prior to the first study drug administration;

20. 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.