Trandolapril 4 mg Tablet Under Fasting Conditions
Condition: Healthy
Intervention: Trandolapril 4 mg Tablets; Mavik® 4 mg Tablets
Intervention description: 1 x 4 mg, single-dose fasting; 1 x 4 mg, single-dose fasting
Intervention MeSH terms: Trandolapril
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

Summary:

      The objective of this study is to compare the rate and extent of absorption of trandolapril
      from a test formulation of Trandolapril 4 mg Tablets versus the reference Mavik® 4 mg Tablets
      under fasting conditions.
    

Eligibility criteria:

        Inclusion Criteria

          -  Non-smoking male or female with a minimum age of 18 years (i.e. non-smoker or
             non-tobacco user for at least 90 days prior to pre-study medical screening).

          -  Body Mass Index (BMI = weight/height2) greater than or equal to 19.0 kg.m2 and less
             than or equal to 30.0 kg/m2.

          -  Normal findings in the physical examination, 12-lead ECG and vital signs (blood
             pressure between 100-140/60-90 mmHg, heart rate between 50-100 beats/min, temperature
             between 35.8°C and 37.5°C).

          -  Negative for drugs of abuse, nicotine, hepatitis B-surface antigen, hepatitis C and
             HIV, and for female subjects, pregnancy (serum β-CG).

          -  No clinical laboratory values outside of the acceptable range as defined by BCR,
             unless the Principal Investigator decides they are not clinically significant.

          -  Female subjects who are surgically sterile for at least six months or post-menopausal
             for at least one year, or who will avoid pregnancy prior to the study, during the
             study and up until one month after the end of the study.

        Exclusion Criteria

          -  Known history of hypersensitivity to trandolapril (e.g. Mavik®) other ACE inhibitors
             such as captopril, benazepril, enalapril, lisinopril, ramipril, quinapril, or
             cilazapril or angiotensin receptor agonists such as losartan, candesartan, eprosartan,
             irbesartan, telmisartan, or valsartan.

          -  Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine,
             musculoskeletal, neurological, hematological, liver or kidney disease, unless judged
             not clinically significant by the Principal Investigator or medical designate.

          -  Known history or presence of food allergies, or any condition known to interfere with
             the absorption, distribution, metabolism, or excretion of drugs.

          -  Any clinically significant illness during the last four weeks prior to entry into this
             study.

          -  Presence of any significant physical or organ abnormality.

          -  Any subject with a history of drug abuse.

          -  Any history or evidence of psychiatric or psychological disease (including depression)
             unless deemed not clinically significant by the Principal Investigator, or medical
             designate.

          -  Use of any prescription medication within 14 days preceding entry into this study.

          -  Use of over the counter (OTC) medication within seven days preceding entry into this
             study (except for spermicidal/barrier contraceptive products).

          -  Female subjects: use of contraceptives (oral, transdermal, implant, Mirena® IUD)
             within 30 days prior to drug administration or a depot injection of progestogen drug
             (e.g. Depo-Provera®) within one year prior to drug administration.

          -  Female subjects: presence of pregnancy or lactation.

          -  Any subject who has had blood drawn within 56 days preceding this study, taken during
             the conduct of any clinical study at a facility other than BCR, or within the lockout
             period specified by a previous study conducted at BCR.

          -  Participation in a clinical trial with an investigational drug within 30 days
             preceding this study.

          -  Any subject who has donated blood within 56 days preceding this study.

          -  Any subject who has participated as a plasma donor in a plasmapheresis program within
             seven days preceding this study.

          -  Significant or recent history of asthma (after 12 years of age).

          -  Any subject with a recent (less than one year) history of alcohol abuse.

          -  Known history of frequent headaches or migraines.

          -  Known history of hereditary or idiopathic angioedema.

          -  Any history of severe allergic reaction (including drugs, food, insect bites,
             environmental allergens).

          -  Intolerance to venipuncture.

          -  Any clinically significant surgery within 4 weeks prior to the administration of the
             study medication.

          -  Use of any drugs 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 administration of the study medication.

          -  Difficulty swallowing study medication.

          -  Difficulty fasting or consuming standard meals.