Trandolapril 4 mg Tablet Under Non-Fasting Conditions

NCT00840073 | Completed Phase 1 Results

• 1 other identifier: 2004-842
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Cmax - Maximum Observed Concentration

  Bioequivalence based on Cmax

  Blood samples collected over 72 hour period

• AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)

  Bioequivalence based on AUC0-inf

  Blood samples collected over 72 hour period

• AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)

  Bioequivalence based on AUC0-t

  Blood samples collected over 72 hour period

Secondary Outcomes (2)

• Cmax - Trandolaprilat

  Blood samples collected over 72 hour period

• AUC0-72 - Trandolaprilat

  Blood samples collected over 72 hour period

Study Arms (2)

Trandolapril

EXPERIMENTAL

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

Drug: Trandolapril 4 mg Tablets

Mavik®

ACTIVE COMPARATOR

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

Drug: Mavik® 4 mg Tablets

Interventions

Trandolapril 4 mg Tablets DRUG

1 x 4 mg, single-dose fed

Trandolapril

Mavik® 4 mg Tablets DRUG

1 x 4 mg, single-dose fed

Mavik®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

Pharma Medica Research Inc.

Toronto, Ontario, M1R 5A3, Canada

Location

MeSH Terms

Interventions

trandolapril

Results Point of Contact

• Title: Manager, Biopharmaceutics
• Organization: Teva Pharmaceuticals USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• Xueyu (Eric) Chen, M.D., Ph. D.

  Pharma Medica

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: February 10, 2009
• Study Start: October 1, 2004
• Primary Completion: November 1, 2004
• Study Completion: November 1, 2004
• Last Updated: August 20, 2024
• Results First Posted: August 18, 2009

Record last verified: 2024-08

Locations

CA (1)