To Determine Bioequivalence Under Fed ConditionsPhase 1NCT01380431

A Comparative Bioavailability Study of Lisinopril Tablets, 40 mg - Effect of Food Study

A Phase 1 study testing Lisinopril in people with To Determine Bioequivalence Under Fed Conditions, run by Par Pharmaceutical, Inc. at 1 site in United States.

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 purpose of this study is to compare the bioavailability of Par Lisinopril 40 mg Tablets and IPR Pharmaceuticals, Inc. Zestril (R). Read more about this study

Who is it for?: Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: To Determine Bioequivalence Under Fed Conditions
What is being tested?: Lisinopril
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: Aug 1999to Oct 1999
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 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Males, healthy, 18-50 years of age,
No more than plus or minus 15% from ideal weight for subject's height as defined by Metropolitan Life Insurance Company Statistical Bulletin 1983,
Without a history of asthma, angioedema, hypertension, psychiatric illness, organ-system (cardiovascular, neurological, hematopoietic, renal, pulmonary, endocrine, or gastrointestinal,) disorders, ongoing infectious diseases, alcohol or drug abuse as determined by a medical history and/or physical examination within 30 days prior to the start of the study. Deviations may be acceptable if deemed not clinically significant by the investigator.
Blood chemistry (including alkaline phosphatase, glucose, ALt, AST, LDH, BUN, GGT, creatinine, bilirubin, electrolytes), hematology (including hemoglobin, hematocrit, red blood cell count, white blood cell count, differential, platelet count), and urinalysis values within clinically acceptable limits upon evaluation by the investigator. The above tests will be performed within 30 days prior to the start of the study.
No prescription drugs within 14 days, or OTC preparations (with the exception of acetaminophen, vitamins, medicated lozenges, dietary supplements and topical medications) within 7 days of the first drug administration, each period. Deviations may be acceptable if evaluated by the investigator and determined not to be clinically significant.
No alcohol consumption for at least 48 hours prior to drug administration until after the last blood collection, each period.

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No known allergy to lisinopril or other ACE (angiotensin converting enzyme) inhibitors, such as captopril and enalapril, or to atropine.
Acceptable electrocardiogram: sinus rhythm with no evidence of AV block or ischemic changes.
At screening and check-in for each period, subjects must have blood pressure and pulse rate within the following ranges: Systolic blood pressure (110-150 mmHg); Diastolic blood pressure (70-95 mmHg); Pulse (50-105 bpm). Minor deviations (1-3 mmHg) at check-in may be acceptable at the discretion of the physician investigator. For all except the first period check-in, if a subject's vital signs measurements fall outside the range specified above, the subject may, at the discretion of the physician investigator, be allowed to remain enrolled until 0-hour measurements are made. If the 0-hour protocol vital signs requirements are met, the investigator may allow dosing and the subject's continuation in the study. If 0-hour vital signs requirements are not met, the subject will not be dosed and must be withdrawn from the study. The blood pressure and pulse will be measured after the subject has been seated at least three minutes. Subjects with blood pressure and pulse measurements outside the ranges will have their vital signs measurements repeated according to Standard Operating Procedure.
No caffeine for at least 48 hours prior to dosing until after the last blood collection, each period.
Negative HIV 1, hepatitis B surface antigen and urine screen for drugs of abuse within 30 days prior to the start of the study.

Who cannot join

All Females, and males younger than 18 years of age or older than 50 years of age are not eligible to participate in this study.
A weight that is more than plus or minus 15% from ideal weight for subject's height as defined by Metropolitan Life Insurance Company Statistical Bulletin 1983.
A medical history of asthma, angioedema hypertension, psychiatric illness, organ-system (cardiovascular, neurological, hepatic, hematopoietic, renal, pulmonary, endocrine, or gastrointestinal) disorders, ongoing infectious diseases, alcohol or drug abuse within 30 days prior to start of the study.
Blood chemistry (including alkaline phosphatase, glucose, ALt, AST, LDH, BUN, GGT, creatinine, bilirubin, electrolytes), hematology (including hemoglobin, hematocrit, red blood cell count, white blood cell count, differential, platelet count), and urinalysis values not within clinically acceptable limits upon evaluation by the investigator. The above tests will be performed within 30 days prior to the start of the study.
Evidence of usage of prescription drugs within 14 days, or OTC preparations (with the exception of acetaminophen, vitamins, medicated lozenges, dietary supplements and topical medications) within 7 days of the first drug administration, each period.
Alcohol consumption within 48 hours prior to drug administration until.

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Known allergy to lisinopril or other ACE (angiotensin converting enzyme) inhibitors, such as captopril and enalapril, or to atropine.
Unacceptable electrocardiogram: sinus rhythm with evidence of AV block or ischemic changes.
Blood pressure and pulse rate outside of the following ranges: Systolic blood pressure (110-150 mmHg); Diastolic blood pressure (70-95 mmHg); Pulse (50-105 bpm).
Evidence of caffeine use within the last 48 hours, prior to dosing, or through the study up to and after the last blood collection, each period.
A positive HIV 1, hepatitis B surface antigen and urine screen for drugs of abuse within 30 days prior to the start of the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

PharmaKinetics Laboratories, Inc.
Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: Randomized, Open-label, Three Treatment Crossover Comparative Bioavailability Study of Lisinopril Tablets, 40 mg - Effect of Food Study

The purpose of this study is to compare the bioavailability of Par Lisinopril 40 mg Tablets and IPR Pharmaceuticals, Inc. Zestril (R).

Read the detailed description

To compare the bioavailability of Par Lisinopril 40 mg Tablets and IPR Pharmaceuticals, Inc. Zestril (R), 40 mg - Effect of Food Study

Conditions: To Determine Bioequivalence Under Fed Conditions
Being tested: Lisinopril
Keywords: bioequivalence, lisinopril, fed
Medical subject headings: Lecithin Cholesterol Acyltransferase Deficiency

What participants receive

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

LisinoprilDrug
Also called Zestril (R) Tablets, 40 mg, single, oral dose
Tablets, 40 mg, single oral dose
lisinoprilDrug
Also called Zestril (R) Tablets, 40 mg, single, oral dose
Tablets, 40 mg, single, oral dose
LisinoprilDrug
Also called Zestril (R) Tablets, 40 mg, single, oral dose
50% of subjects received the Par formulated product.

Study groups in NCT01380431
Study group	Role	What they receive
A	Experimental	Subjects received the Par formulated product. Receives: Drug: Lisinopril
B	Active comparator	Subjects received the IPR (Zeneca Pharmaceuticals) formulated product. Receives: Drug: lisinopril
C	Active comparator	Subjects received the IPR (Zeneca Pharmaceuticals) formulated product. Receives: Drug: Lisinopril

What is being measured

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

Bioequivalence
Comparable food effect; The ratios of the test nd reference means and geometric means using the lease-squares means AUCo-t, AUCo-inf and Cmax should be within 80% - 125%.

Timeline

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

Aug 1999Oct 1999

First posted27 Jun 2011 (estimated)
Study startAug 1999
Primary completionOct 1999
Study completionOct 1999

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for To Determine Bioequivalence Under Fed ConditionsStudies 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
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01380431
Sponsor's protocol ID: 11508
Status last verified: Jun 2011
First submitted: 1 Apr 2008
Last updated: 27 Jun 2011
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Open-label, Three Treatment Crossover Comparative Bioavailability Study of Lisinopril Tablets, 40 mg - Effect of Food Study
ClinicalTrials.gov ID: NCT01380431
Acronym / sponsor ID: 11508
Conditions: To Determine Bioequivalence Under Fed Conditions
Keywords: bioequivalence, lisinopril, fed
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Par Pharmaceutical, Inc.Industry (pharma, biotech, devices)
Collaborators: PharmaKinetics Laboratories Inc.
Study start: Aug 1999
Primary completion: Oct 1999 (actual)
Study completion: Oct 1999 (actual)
First posted: 27 Jun 2011 (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.

The purpose of this study is to compare the bioavailability of Par Lisinopril 40 mg Tablets and IPR Pharmaceuticals, Inc. Zestril (R).

Detailed description

To compare the bioavailability of Par Lisinopril 40 mg Tablets and IPR Pharmaceuticals, Inc. Zestril (R), 40 mg - Effect of Food Study

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
A	Experimental	Drug: LisinoprilSubjects received the Par formulated product.
B	Active comparator	Drug: lisinoprilSubjects received the IPR (Zeneca Pharmaceuticals) formulated product.
C	Active comparator	Drug: LisinoprilSubjects received the IPR (Zeneca Pharmaceuticals) formulated product.

Who may qualify

Ages: 18 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

Males, healthy, 18-50 years of age,
No more than plus or minus 15% from ideal weight for subject's height as defined by Metropolitan Life Insurance Company Statistical Bulletin 1983,
Without a history of asthma, angioedema, hypertension, psychiatric illness, organ-system (cardiovascular, neurological, hematopoietic, renal, pulmonary, endocrine, or gastrointestinal,) disorders, ongoing infectious diseases, alcohol or drug abuse as determined by a medical history and/or physical examination within 30 days prior to the start of the study. Deviations may be acceptable if deemed not clinically significant by the investigator.
Blood chemistry (including alkaline phosphatase, glucose, ALt, AST, LDH, BUN, GGT, creatinine, bilirubin, electrolytes), hematology (including hemoglobin, hematocrit, red blood cell count, white blood cell count, differential, platelet count), and urinalysis values within clinically acceptable limits upon evaluation by the investigator. The above tests will be performed within 30 days prior to the start of the study.
No prescription drugs within 14 days, or OTC preparations (with the exception of acetaminophen, vitamins, medicated lozenges, dietary supplements and topical medications) within 7 days of the first drug administration, each period. Deviations may be acceptable if evaluated by the investigator and determined not to be clinically significant.

Key exclusion criteria (11 listed)

All Females, and males younger than 18 years of age or older than 50 years of age are not eligible to participate in this study.
A weight that is more than plus or minus 15% from ideal weight for subject's height as defined by Metropolitan Life Insurance Company Statistical Bulletin 1983.
A medical history of asthma, angioedema hypertension, psychiatric illness, organ-system (cardiovascular, neurological, hepatic, hematopoietic, renal, pulmonary, endocrine, or gastrointestinal) disorders, ongoing infectious diseases, alcohol or drug abuse within 30 days prior to start of the study.
Blood chemistry (including alkaline phosphatase, glucose, ALt, AST, LDH, BUN, GGT, creatinine, bilirubin, electrolytes), hematology (including hemoglobin, hematocrit, red blood cell count, white blood cell count, differential, platelet count), and urinalysis values not within clinically acceptable limits upon evaluation by the investigator. The above tests will be performed within 30 days prior to the start of the study.
Evidence of usage of prescription drugs within 14 days, or OTC preparations (with the exception of acetaminophen, vitamins, medicated lozenges, dietary supplements and topical medications) within 7 days of the first drug administration, each period.

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
LisinoprilAlso: Zestril (R) Tablets, 40 mg, single, oral doseTablets, 40 mg, single oral dose	Drug	C
lisinoprilAlso: Zestril (R) Tablets, 40 mg, single, oral doseTablets, 40 mg, single, oral dose	Drug	B
LisinoprilAlso: Zestril (R) Tablets, 40 mg, single, oral dose50% of subjects received the Par formulated product.	Drug	A

Primary outcome

Bioequivalence
Comparable food effect; The ratios of the test nd reference means and geometric means using the lease-squares means AUCo-t, AUCo-inf and Cmax should be within 80% - 125%.

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 27 Jun 2011.

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.

Clifford L Ferguson, MD principal investigator

PharmaKinetics Laboratories Inc.

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 Lisinopril in people with To Determine Bioequivalence Under Fed Conditions, run by Par Pharmaceutical, Inc. at 1 site in United States.

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 11 inclusion and 11 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 27 Jun 2011. 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 United States. 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?

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?

Bioequivalence. 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 NCT01380431.

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 27 Jun 2011.