HealthyPhase 1NCT00840073

Trandolapril 4 mg Tablet Under Non-Fasting Conditions

A Phase 1 study testing Trandolapril 4 mg Tablets and Mavik® 4 mg Tablets in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Trandolapril 4 mg Tablets and Mavik® 4 mg Tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteCanada
Study dates: Oct 2004to Nov 2004
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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).

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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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Pharma Medica Research Inc.
Toronto, Ontario, M1R 5A3

Other trials in Canada

About this study

Official title: A Single-Dose, Comparative Bioavailability Study of Two Formulations of Trandolapril 4 mg Tablets Under Fed Conditions.

Read the detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Conditions: Healthy
Being tested: Trandolapril 4 mg Tablets, Mavik® 4 mg Tablets
Keywords: Bioequivalence, Healthy Subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Trandolapril 4 mg TabletsDrug
1 x 4 mg, single-dose fed
Mavik® 4 mg TabletsDrug
1 x 4 mg, single-dose fed

Study groups in NCT00840073
Study group	Role	What they receive
Trandolapril	Experimental	Trandolapril 4 mg Tablet (test) dosed in first period followed by Mavik® 4 mg Tablet (reference) dosed in second period Receives: 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 Receives: Drug: Mavik® 4 mg Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax - Maximum Observed Concentration
Bioequivalence based on Cmax
Measured: 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
Measured: 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
Measured: Blood samples collected over 72 hour period

Secondary outcomes (2)

Cmax - Trandolaprilat
Informational Purposes Only
Measured: Blood samples collected over 72 hour period
AUC0-72 - Trandolaprilat
Informational Purposes Only
Measured: Blood samples collected over 72 hour period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2004Nov 2004

First posted10 Feb 2009 (estimated)
Study startOct 2004
Primary completionNov 2004
Study completionNov 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00840073
Sponsor's protocol ID: 2004-842
Status last verified: Aug 2024
First submitted: 6 Feb 2009
Last updated: 20 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Dose, Comparative Bioavailability Study of Two Formulations of Trandolapril 4 mg Tablets Under Fed Conditions.
ClinicalTrials.gov ID: NCT00840073
Acronym / sponsor ID: 2004-842
Conditions: Healthy
Keywords: Bioequivalence, Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
Study start: Oct 2004
Primary completion: Nov 2004 (actual)
Study completion: Nov 2004 (actual)
First posted: 10 Feb 2009 (estimated)
Results: Posted 18 Aug 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Trandolapril	Experimental	Drug: Trandolapril 4 mg TabletsTrandolapril 4 mg Tablet (test) dosed in first period followed by Mavik® 4 mg Tablet (reference) dosed in second period
Mavik®	Active comparator	Drug: Mavik® 4 mg TabletsMavik® 4 mg Tablet (reference) dosed in first period followed by Trandolapril 4 mg Tablet (test) dosed in second period

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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.

Key exclusion criteria (14 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Trandolapril 4 mg Tablets1 x 4 mg, single-dose fed	Drug	Trandolapril
Mavik® 4 mg Tablets1 x 4 mg, single-dose fed	Drug	Mavik®

Primary outcome

Cmax - Maximum Observed Concentration
Time frame: Blood samples collected over 72 hour period
Bioequivalence based on Cmax
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Time frame: Blood samples collected over 72 hour period
Bioequivalence based on AUC0-inf
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
Time frame: Blood samples collected over 72 hour period
Bioequivalence based on AUC0-t

2 secondary outcomes

Cmax - Trandolaprilat
Time frame: Blood samples collected over 72 hour period
AUC0-72 - Trandolaprilat
Time frame: Blood samples collected over 72 hour period

Results and safety

Results posted to the registry on 18 Aug 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Trandolapril (Test) First	25	25
Mavik® (Reference) First	25	25

Primary outcome: Cmax - Maximum Observed Concentration

Time frame: Blood samples collected over 72 hour period. Mean (Standard Deviation). Unit: ng/mL

Measure	Trandolapril n = 50	Mavik® n = 50
Value	5.2604 (3.8238)	5.4938 (3.7393)

Trandolapril vs Mavik®: Ratio of Geometric Means: 96.00 (90% CI 85.13 to 108.27)

Population analysed: Data from all subjects who completed the study were included in the statistical analysis. Data from two subjects who did not complete was also included in statistical analysis since the 72 hour blood draw that was missed does not affect the results for Trandolapril.

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

Time frame: Blood samples collected over 72 hour period. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Trandolapril n = 20	Mavik® n = 22
Value	7.0104 (1.9298)	7.9967 (2.8867)

Trandolapril vs Mavik®: Ratio of Geometric Means: 103.81 (90% CI 96.72 to 111.41)

Population analysed: Data from all subjects who completed the study were included in the statistical analysis. Not all data from completed subjects could be used to determine AUC0-inf.

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

Time frame: Blood samples collected over 72 hour period. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Trandolapril n = 50	Mavik® n = 50
Value	6.9056 (2.7329)	6.7143 (2.4740)

Trandolapril vs Mavik®: Ratio of Geometric Means: 102.37 (90% CI 97.34 to 107.65)

2 secondary outcomes are reported in the full results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

Pharma Medica

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Trandolapril 4 mg Tablets and Mavik® 4 mg Tablets in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax - Maximum Observed Concentration (time frame: Blood samples collected over 72 hour period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00840073.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.