HealthyPhase 1NCT02171494

Bioequivalence of IVAX Warfarin Tablets and Coumadin Brand Warfarin Tablets in Healthy Volunteers

A Phase 1 study testing IVAX Warfarin and BMS Coumadin in people with Healthy, run by Boehringer Ingelheim.

Completed

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

Trial summary

To establish the bioequivalence of 2x5 mg of IVAX warfarin /formulation tablet vs. 10 mg of Coumadin / formulation tablet Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: IVAX Warfarin and BMS Coumadin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: No sites listed yet
Study dates: Sep 2008to Oct 2008
Phase: Phase 1
Are there results?: None posted in the registry

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 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate, temp), 12-lead electrocardiogram, clinical laboratory tests, without clinically significant abnormal findings
Age ≥ 18 and Age ≤ 45 years
Body Mass Index (BMI) ≥ 18.0 and BMI ≤ 30.0 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation

Who cannot join

A history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results
A history of allergic or adverse responses to warfarin or any comparable or similar product
Subjects who (for whatever reason) had been on an abnormal diet or had substantial changes in eating habits within 30 days prior to study initiation
Subjects could not have made a blood donation of one pint or more within 30 days prior to study initiation
Subjects could not have made a plasma donation within 14 days of study initiation
Participation in a clinical trial within 30 days prior to study initiation

Show all 16Show fewer

Use of any over-the-counter (OTC) medication, including vitamins, herbal products, and dietary supplements, within 7 days prior to or during the study
Use of any prescription medication within 7 days prior to or during the study
Treatment with any known enzyme altering drugs such as barbiturates, phenothiazines, cimetidine, carbamazepine, phenytoin, rifampin, rifabutin, glucocorticoids, diltiazem, ketoconazole, MAOI (monoamine oxidase inhibitor), antidepressants, neuroleptics, verapamil, quinidine, erythromycin, etc., within 30 days prior to or during the study
Smoking or use of tobacco products within 6 months prior to or during the study. Smoking status was verified by a urine cotinine screen.
Female subjects
Positive blood screen for Human Immunodeficiency Virus, Hepatitis B, or Hepatitis C
Positive screen for alcohol, drugs of abuse, or cotinine and history or presence of alcoholism or drug abuse within 6 months prior to the study start
Subjects could not have taken aspirin or any aspirin-containing medications or any antiplatelet or anticoagulant medication within 7 days prior to the study, for the duration of the study and for 14 days after the last dose of study medication
aPTT (activated partial thromboplastin time) or INR (international normalized ratio) results unacceptable to principal investigator
Inability to comply with dietary regimen of trial site

About this study

Official title: Bioequivalence of 2x5 mg of IVAX Warfarin /Formulation Tablet Compared to 10 mg of Coumadin /Formulation Tablet Following Oral Administration in Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Two-treatment, Two-sequence Crossover Study) Under Fasted Conditions

To establish the bioequivalence of 2x5 mg of IVAX warfarin /formulation tablet vs. 10 mg of Coumadin / formulation tablet

Conditions: Healthy
Being tested: IVAX Warfarin, BMS Coumadin

What participants receive

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

IVAX WarfarinDrug
BMS CoumadinDrug

Study groups in NCT02171494
Study group	Role	What they receive
IVAX warfarin	Experimental	Treatment A: IVAX warfarin Receives: Drug: IVAX Warfarin
BMS coumadin	Active comparator	Treatment B: BMS coumadin tablets Receives: Drug: BMS Coumadin

What is being measured

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

AUC0-infinity (area under the concentration-time curve over the time interval from 0 extrapolated to infinity)
Measured: pre-dose and 0:15, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 5:00, 6:00, 8:00,10:00 12:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 and 216:00 hours after dosing on day 1 and day 22
Cmax (maximum measured concentration of the analyte in plasma)
Measured: pre-dose and 0:15, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 5:00, 6:00, 8:00,10:00 12:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 and 216:00 hours after dosing on day 1 and day 22

Secondary outcomes (7)

AUC0-tz (area under the concentration-time curve over the time interval from 0 to the time of the last quantifiable data point)
Measured: pre-dose and 0:15, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 5:00, 6:00, 8:00,10:00 12:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 and 216:00 hours after dosing on day 1 and day 22
tmax (time from dosing to the maximum concentration)
Measured: pre-dose and 0:15, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 5:00, 6:00, 8:00,10:00 12:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 and 216:00 hours after dosing on day 1 and day 22
λz (terminal rate constant in plasma)
Measured: pre-dose and 0:15, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 5:00, 6:00, 8:00,10:00 12:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 and 216:00 hours after dosing on day 1 and day 22
t1/2 (terminal half-life of the analyte in plasma)
Measured: pre-dose and 0:15, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 5:00, 6:00, 8:00,10:00 12:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 and 216:00 hours after dosing on day 1 and day 22
MRTpo (mean residence time of the analyte in the body after oral administration)
Measured: pre-dose and 0:15, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 5:00, 6:00, 8:00,10:00 12:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 and 216:00 hours after dosing on day 1 and day 22
CL/F (apparent clearance after extravascular administration)
Measured: pre-dose and 0:15, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 5:00, 6:00, 8:00,10:00 12:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 and 216:00 hours after dosing on day 1 and day 22
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: pre-dose and 0:15, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 5:00, 6:00, 8:00,10:00 12:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 and 216:00 hours after dosing on day 1 and day 22

Timeline

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

Sep 2008Oct 2008

First posted24 Jun 2014 (estimated)
Study startSep 2008
Primary completionOct 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02171494
Sponsor's protocol ID: 1160.68
Status last verified: Jun 2014
First submitted: 20 Jun 2014
Last updated: 24 Jun 2014
Results posted: 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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bioequivalence of 2x5 mg of IVAX Warfarin /Formulation Tablet Compared to 10 mg of Coumadin /Formulation Tablet Following Oral Administration in Healthy Male Volunteers (an Open-label, Randomised, Single-dose, Two-treatment, Two-sequence Crossover Study) Under Fasted Conditions
ClinicalTrials.gov ID: NCT02171494
Acronym / sponsor ID: 1160.68
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: Oct 2008 (actual)
First posted: 24 Jun 2014 (estimated)
Results: Not posted in the source record

Clinical summary

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

To establish the bioequivalence of 2x5 mg of IVAX warfarin /formulation tablet vs. 10 mg of Coumadin / formulation tablet

Study design

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

Arm	Type	Receives
IVAX warfarin	Experimental	Drug: IVAX WarfarinTreatment A: IVAX warfarin
BMS coumadin	Active comparator	Drug: BMS CoumadinTreatment B: BMS coumadin tablets

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure, pulse rate, temp), 12-lead electrocardiogram, clinical laboratory tests, without clinically significant abnormal findings
Age ≥ 18 and Age ≤ 45 years
Body Mass Index (BMI) ≥ 18.0 and BMI ≤ 30.0 kg/m2
Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation

Key exclusion criteria (16 listed)

A history of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results
A history of allergic or adverse responses to warfarin or any comparable or similar product
Subjects who (for whatever reason) had been on an abnormal diet or had substantial changes in eating habits within 30 days prior to study initiation
Subjects could not have made a blood donation of one pint or more within 30 days prior to study initiation
Subjects could not have made a plasma donation within 14 days of study initiation

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
IVAX Warfarin	Drug	IVAX warfarin
BMS Coumadin	Drug	BMS coumadin

Primary outcome

AUC0-infinity (area under the concentration-time curve over the time interval from 0 extrapolated to infinity)
Time frame: pre-dose and 0:15, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 5:00, 6:00, 8:00,10:00 12:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 and 216:00 hours after dosing on day 1 and day 22
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: pre-dose and 0:15, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 5:00, 6:00, 8:00,10:00 12:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 and 216:00 hours after dosing on day 1 and day 22

7 secondary outcomes

AUC0-tz (area under the concentration-time curve over the time interval from 0 to the time of the last quantifiable data point)
Time frame: pre-dose and 0:15, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 5:00, 6:00, 8:00,10:00 12:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 and 216:00 hours after dosing on day 1 and day 22
tmax (time from dosing to the maximum concentration)
Time frame: pre-dose and 0:15, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 5:00, 6:00, 8:00,10:00 12:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 and 216:00 hours after dosing on day 1 and day 22
λz (terminal rate constant in plasma)
Time frame: pre-dose and 0:15, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 5:00, 6:00, 8:00,10:00 12:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 and 216:00 hours after dosing on day 1 and day 22
t1/2 (terminal half-life of the analyte in plasma)
Time frame: pre-dose and 0:15, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 5:00, 6:00, 8:00,10:00 12:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 and 216:00 hours after dosing on day 1 and day 22
MRTpo (mean residence time of the analyte in the body after oral administration)
Time frame: pre-dose and 0:15, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 5:00, 6:00, 8:00,10:00 12:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 and 216:00 hours after dosing on day 1 and day 22
CL/F (apparent clearance after extravascular administration)
Time frame: pre-dose and 0:15, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 5:00, 6:00, 8:00,10:00 12:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 and 216:00 hours after dosing on day 1 and day 22
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: pre-dose and 0:15, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 5:00, 6:00, 8:00,10:00 12:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 and 216:00 hours after dosing on day 1 and day 22

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2014.

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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IVAX Warfarin and BMS Coumadin in people with Healthy, run by Boehringer Ingelheim.

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 4 inclusion and 16 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 24 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

AUC0-infinity (area under the concentration-time curve over the time interval from 0 extrapolated to infinity) (time frame: pre-dose and 0:15, 0:30, 1:00, 1:30, 2:00, 2:30, 3:00, 3:30, 4:00, 5:00, 6:00, 8:00,10:00 12:00, 24:00, 36:00, 48:00, 72:00, 96:00, 120:00, 144:00, 168:00, 192:00 and 216:00 hours after dosing on day 1 and day 22). The study lists 2 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 NCT02171494.

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 24 Jun 2014.