Status:
COMPLETED
The Bioequivalence Study of Two Different Formulations of Candesartan Cilexetil After a Single Oral Dose Administration Under Fasting Conditions
Lead Sponsor:
Pharmtechnology LLC
Collaborating Sponsors:
Altasciences Company Inc.
Conditions:
Bioequivalence
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 formulati...
Detailed Description
This is a single center, randomized, 2-treatment, 2-period, 2-sequence, crossover, single dose study design, in which 40 healthy adult subjects received one of the study treatments during each study p...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form (ICF)
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Healthy Caucasian adult male or female
- 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:
- bilateral oophorectomy; and
- absence of menses for at least 90 days prior to the first study drug administration; and
- 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
- Female who is lactating at screening
- Female who is pregnant according to the pregnancy test at screening or prior to the first study drug administration
- Seated pulse rate less than 50 Beats per Minute (bpm) at the screening visit and prior to the first study drug administration
- Seated blood pressure below 110/60 mmHg at the screening visit and prior to the first study drug administration
- 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
- 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
- History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
- Presence of clinically significant ECG abnormalities at the screening visit, as defined by medical judgment
- History of rare hereditary problems of galactose and/or lactose intolerance, lactase deficiency or glucose-galactose malabsorption
- 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)
- Any clinically significant illness in the 28 days prior to the first study drug administration
- 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
- Any history of tuberculosis
- Positive test result for alcohol and/or drugs of abuse at screening or prior to the first drug administration
- Positive screening results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG) or Hepatitis C Virus (HCV) tests
- Inclusion in a previous group for this clinical study
- Intake of candesartan in the 28 days prior to the first study drug administration
- Intake of an Investigational Product (IP) in the 28 days prior to the first study drug administration
- Donation of 50 mL or more of blood in the 28 days prior to the first study drug administration
- 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
Key Trial Info
Start Date :
July 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04012307
Start Date
July 11 2019
End Date
August 14 2019
Last Update
November 18 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Altasciences Company Inc.
Mount Royal, Quebec, Canada, H3P 3P1