To Determine Bioequivalence Under Fed ConditionsPhase 1NCT00652600
Bioavailability Study of Propranolol Under Fed Conditions
A Phase 1 study testing Propranolol and Inderal-LA in people with To Determine Bioequivalence Under Fed Conditions, run by Par Pharmaceutical, Inc..
Trial summary
To compare the single-dose bioavailability of Propranolol 160 Mg ER Capsules with Inderal-La Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- To Determine Bioequivalence Under Fed Conditions
- What is being tested?
- Propranolol and Inderal-LA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Dec 2005
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects enrolled in the study will be members of the community at large. The Recruitment advertisements may use various media types (E.g. ratio, newspapers, SFBC Anapharm Website, SFBC Anapharm volunteer's database). Subjects must meet all the following criteria in order to be included in the study.
- Male and female, non-smoker, 18 years of age and older
- Capable of consent
- BMI ≥ 19.0 and > 30.0 kg/ m2.
Who cannot join
- Subjects to whom any of the following applies will be excluded from the study.
- Clinically significant illness within 4 weeks prior to the administration of the study medication
- Clinically significant surgery within 4 weeks prior to the administration of the study medication.
- Any clinically significant abnormality found during medical screening.
- Any reason which, in the opinion of the Medical Sub- Investigator, would prevent the subject from participating in the study.
- Abnormal laboratory tests judged clinically significant.
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- Positive testing for hepatitis B, hepatitis C, or HIV at screening.
- ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 100 or over 140 mmHg, diastolic blood pressure lower than 60 or over 90 mmHg, or heart rate less than 60 or over 100 bpm) at screening.
- History of significant alcohol abuse or drug abuse within one year prior to the screening visit.
- Regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week [ 1 Unit = 150mL of wine, 360 mL of beer, or 45mL of 40% alcohol])
- Use of soft drugs ( such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP] and crack) within 1 year prior to the screening visit or positive urine drug at screening.
- History of allergic reactions to heparin, propranolol, or other related drugs.
- --Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin,glucocorticoids, omerprazole; examples of inhibitors: antidepressants (SSRI), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to administration of the study medication.
- Use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
- Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known as interface with the absorption, distribution, metabolism, or excretion of the drug.
- Any clinically significant history or presence of clinically significant neurological, endocrinal, cardiovascular, pulmonary, hematologic, psychiatric, or metabolic disease.
- Use of prescription medication within 14 days prior to administration of a study medication or over the counter products (including natural food supplements, vitamins, garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption and hormonal contraceptive.
- Difficulty to swallow study medication.
- Use of any tobacco products in the 6 months proceeding drug administration.
- Any food allergy, intolerance, restriction or special diet that, in the opinion of the Medical Sub- Investigator, could contraindicate the subject's participation in this study.
- A depot injection or an implant of any drug (other than contraceptives) within 3 months prior to administration of study medication.
- Donation of plasma (500 Ml) within 7 days to drug administration. Donation or loss of hole blood (excluding the volume of blood drawn during the screening procedures of this study) prior to administration of the study medication as follows.
- 50mL to 300mL of whole blood within 30 days, 301 mL to 500 ml of whole blood within 45days or more than 500 mL of whole blood within 56 days prior to drug administration..
- History bronchial asthma and bronchospastic diseases.
- History of known presence of cardiogenic shock, sinus bradycardia, Wolff-Parkinson White Syndrome, congestive heart failure or angina.
- Clinically significant history of diabetes.
- Clinically significant history of hyperthyroidism.
- Breast- feeding subject.
- Positive urine pregnancy test at screening.
- Female subjects of childbearing potential having unprotected sexual intercourse with any non- sterile male partner (i.e. male who ahs not been sterilized by vasectomy for al least 6 months) within 14 days prior to study drug administration. Acceptable methods of contraception:
- Intra-uterine contraceptive device (place al least 4 weeks prior to study drug administration)
- Condom or diaphragm. + spermicide
- Hormonal contraceptives (starting al least 4 weeks prior to study administration)
About this study
Official title: Comparative, Randomized, Single-Dose, 2 Way Cross Over Bioavailability Study of Par Propranolol 160 mg With That of Inderal-LA Propranolol 160 mg in Healthy Subjects Under Fed Conditions.
To compare the single-dose bioavailability of Propranolol 160 Mg ER Capsules with Inderal-La
Read the detailed description
To compare the single -dose bioavailability of Par Propranolol 160 Mg ER capsules with Wyeth Pharmaceuticals, Inderal-LA, Propranolol under fed conditions.
- Being tested
- Propranolol, Inderal-LA
- Keywords
- Bioequivalence, Propranolol ER capsules, 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.
PropranololDrug
Also called Inderal-LA
ER Capsules, 160 mg, single-dose
Inderal-LADrug
Also called Propranolol ER capsules
ER Capsules, 160 mg, single-dose
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Subjects received Par formulated product under fed conditions Receives: Drug: Propranolol |
| B | Active comparator | Subjects received Wyeth Pharmaceuticals formulated product under fed conditions Receives: Drug: Inderal-LA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate and Extend of Absorption
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2008 (estimated)
- Study startSep 2005
- Primary completionDec 2005
- Study completionDec 2005
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Par Pharmaceutical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SFBC Anapharm
- Investigators
- Richard Larouche, Principal investigator, SFBC Anapharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00652600
- Sponsor's protocol ID
- 50233
- Status last verified
- Sep 2017
- First submitted
- 1 Apr 2008
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative, Randomized, Single-Dose, 2 Way Cross Over Bioavailability Study of Par Propranolol 160 mg With That of Inderal-LA Propranolol 160 mg in Healthy Subjects Under Fed Conditions.
- ClinicalTrials.gov ID
- NCT00652600
- Acronym / sponsor ID
- 50233
- Keywords
- Bioequivalence, Propranolol ER capsules, fed
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Par Pharmaceutical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- SFBC Anapharm
- Study start
- Sep 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 4 Apr 2008 (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 compare the single-dose bioavailability of Propranolol 160 Mg ER Capsules with Inderal-La
Detailed description
To compare the single -dose bioavailability of Par Propranolol 160 Mg ER capsules with Wyeth Pharmaceuticals, Inderal-LA, Propranolol under fed conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: PropranololSubjects received Par formulated product under fed conditions |
| B | Active comparator | Drug: Inderal-LASubjects received Wyeth Pharmaceuticals formulated product under fed conditions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects enrolled in the study will be members of the community at large. The Recruitment advertisements may use various media types (E.g. ratio, newspapers, SFBC Anapharm Website, SFBC Anapharm volunteer's database). Subjects must meet all the following criteria in order to be included in the study.
- Male and female, non-smoker, 18 years of age and older
- Capable of consent
- BMI ≥ 19.0 and > 30.0 kg/ m2.
Key exclusion criteria (33 listed)
- Subjects to whom any of the following applies will be excluded from the study.
- Clinically significant illness within 4 weeks prior to the administration of the study medication
- Clinically significant surgery within 4 weeks prior to the administration of the study medication.
- Any clinically significant abnormality found during medical screening.
- Any reason which, in the opinion of the Medical Sub- Investigator, would prevent the subject from participating in the study.
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 |
|---|---|---|
| PropranololAlso: Inderal-LAER Capsules, 160 mg, single-dose | Drug | A |
| Inderal-LAAlso: Propranolol ER capsulesER Capsules, 160 mg, single-dose | Drug | B |
Primary outcome
Rate and Extend of Absorption
Time frame: 24 Hours
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 26 Sep 2017.
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.
Richard Larouche principal investigator
SFBC Anapharm
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Propranolol and Inderal-LA in people with To Determine Bioequivalence Under Fed Conditions, run by Par Pharmaceutical, Inc..
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 33 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 26 Sep 2017. 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?
Rate and Extend of Absorption (time frame: 24 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2017.