Trandolapril 4 mg Tablet Under Non-Fasting Conditions

NCT ID: NCT00840073

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2004-11-30

Brief 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.

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Trandolapril

Trandolapril 4 mg Tablet (test) dosed in first period followed by Mavik® 4 mg Tablet (reference) dosed in second period

Group Type: EXPERIMENTAL

Trandolapril 4 mg Tablets

Intervention Type: DRUG

1 x 4 mg, single-dose fed

Mavik®

Mavik® 4 mg Tablet (reference) dosed in first period followed by Trandolapril 4 mg Tablet (test) dosed in second period

Group Type: ACTIVE_COMPARATOR

Mavik® 4 mg Tablets

Intervention Type: DRUG

1 x 4 mg, single-dose fed

Interventions

Trandolapril 4 mg Tablets

1 x 4 mg, single-dose fed

Intervention Type: DRUG

Mavik® 4 mg Tablets

1 x 4 mg, single-dose fed

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Teva Pharmaceuticals USA

INDUSTRY

Sponsor Role: lead

Principal Investigators

Xueyu (Eric) Chen, M.D., Ph. D.

Role: PRINCIPAL_INVESTIGATOR

Pharma Medica

Locations

Pharma Medica Research Inc.

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

2004-842

Identifier Type: -

Identifier Source: org_study_id