Trandolapril 4 mg Tablet Under Non-Fasting Conditions
Condition: Healthy
Intervention: Trandolapril 4 mg Tablets; Mavik® 4 mg Tablets
Intervention description: 1 x 4 mg, single-dose fed; 1 x 4 mg, single-dose fed
Intervention MeSH terms: Trandolapril
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

Summary:

      The objective of this study is to evaluate the comparative bioavailability between
      trandolapril 4 mg tablets (test) and Mavik® 4 mg Tablets (reference) after a single-dose in
      healthy subjects under fed conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy, non-smoking, male and female subjects, 18 years of age or older.

          -  BMI greater than or equal to 19 and less than or equal to 30.

          -  Negative for HIV, Hepatitis B surface antigen and Hepatitis C antibody, urine drugs of
             abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines
             and methadone), urine cotinine test, serum HCG consistent with pregnancy (females
             only).

          -  No significant diseases or clinically significant findings in a physical examination.

          -  No clinically significant abnormal laboratory values.

          -  No clinically significant findings in the 12-lead electrocardiogram (ECG).

          -  Blood pressure over 90/60 mmHg and less than 140/90 mmHg.

          -  Be informed of the nature of the study and given written consent prior to receiving
             any study procedure.

          -  Females who are surgically sterile for at least six months or postmenopausal for at
             least one year, or who will avoid pregnancy prior to the study, during the study and
             up to one month after the end of the study.

          -  Females who participate in this study are not pregnant and/or non-lactating.

        Exclusion Criteria:

          -  Known history or presence of any clinically significant medical condition.

          -  Known history of food allergies, or any condition know to interfere with the
             absorption, distribution, metabolism or excretion of drugs.

          -  Known or suspected carcinoma.

          -  Presence or history of angioedema.

          -  Known history or presence of hypersensitivity or idiosyncratic reaction to
             trandolapril and/or any other drug substances with similar activity; alcoholism within
             the last 12 months; drug dependence and/or substance abuse; use of tobacco or
             nicotine-containing products, within the last 6 months.

          -  Any clinically significant illness or surgery within 4 weeks prior to drug
             administration.

          -  On a special diet within 4 weeks prior to drug administration (e.g. liquid, protein,
             raw food diet).

          -  Participated in another clinical trial or received an investigational product within
             30 days prior to drug administration.

          -  Donated up to 250 mL of blood within the previous 30 days OR donated from 251 to 500
             mL of blood in the previous 45 days OR donated more than 500 mL of blood in the
             previous 56 days (based on the Canadian Blood Services guideline for blood donation).

          -  Use of any prescription medication within 14 days prior to period 1 dosing. Use of any
             over the counter (OTC) medication within 7 days prior to period 1 dosing (except
             spermicidal/barrier contraceptive products).

          -  Use of any drug known to induce or inhibit hepatic drug metabolism (examples of
             inducers: barbiturates, carbamazepine, phenytoine, glucocorticoids, omeprazole;
             examples of inhibitors: antidepressant (SSRI), cimetidine, diltiazem, macrolides,
             imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days
             prior to period 1 dosing.

          -  Females taking oral or transdermal hormonal contraceptives within 30 days preceding
             period 1 dosing OR Females having taken implanted or injected hormonal contraceptives
             (Depo-Provera) within one year prior to period 1 dosing.

          -  Difficulty fasting or consuming the standard meals.

          -  Do not tolerate venipuncture.