The Bioequivalence Study of Two Different Formulations of Candesartan Cilexetil After a Single Oral Dose Administration Under Fasting Conditions

• Status: Completed
• Trial end date: 2019-08-14
• 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 candesartan in the two formulations 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 candesartan.

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

Details

• Lead Sponsor: Pharmtechnology LLC
• Collaborators: Altasciences Company Inc.; Altasciences Company, Inc.
• Treatments: Candesartan; Candesartan cilexetil

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:

(1) Physiological postmenopausal status, defined as the following:

a) absence of menses for at least one year prior to the first study drug administration (without an alternative medical condition); and b) 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 postmenopausal and has an FSH of < 40 mIU/mL, but meets all other criteria in (1), (2) or (3) above as well as all the other inclusion criteria, screening estradiol serum level must be equal to or below 150 pmol/L. In the case of hysterectomy, if FSH and estradiol do not meet the criteria, eligibility for study participation will be based on medical judgment.

5. Aged at least 18 years but not older than 55 years

6. Body mass index (BMI) within 18.5 kg/m2 to 30.0 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 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. Female who is lactating at screening

2. Female who is pregnant according to the pregnancy test at screening or prior to the first study drug administration

3. Seated pulse rate less than 50 Beats per Minute (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 candesartan 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 (including but not limited to cholecystectomy) 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 clinically significant 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, intake of excessive alcohol, acute or chronic)

11. Any clinically significant illness in the 28 days prior to the first study drug administration

12. 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 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 (HBsAG) or Hepatitis C Virus (HCV) tests

16. Inclusion in a previous group for this clinical study

17. Intake of candesartan 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