HealthyPhase 1NCT00865215
A Relative Bioavailability Study of Propranolol Hydrochloride 160 mg Tablets Under Fasting Conditions
A Phase 1 study testing Propranolol Hydrochloride Extended Release Capsules 160 mg and INDERAL® LA 160 mg Capsules, single dose in people with Healthy, run by Actavis Inc. at 1 site in United States.
Trial summary
The purpose of this study is TO compare the relative bioavailability of Propranolol Hydrochloride Extended Release Capsules 160 mg (Actavis) with that of INDERAL® LA 160 mg Capsules (Wyeth Pharmaceuticals) following a single oral dose (1 x 160 mg) in healthy adult volunteers under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Propranolol Hydrochloride Extended Release Capsules 160 mg and INDERAL® LA 160 mg Capsules, single dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Apr 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers who have been informed of the nature of the study and agree to read, review and sign the informed consent document prior to Period I dosing.
- Volunteers who have completed the screening process within 28 days prior to Period I dosing.
- Volunteers who are healthy adult men and women 18 to 50 years of age, inclusive, at the time of dosing.
- Volunteers who have a body mass index (BMI) between 18-32 kg/m2, inclusive, and weigh at least 110 lbs.
- Volunteers who are healthy as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and by general observations. Any abnormalities/deviations from the normal range that might be considered clinically relevant by the study physician and investigator will be evaluated for individual cases, documented in study files, and agreed upon by both the study physician and investigator prior to enrolling the volunteer in this study and for continued enrollment.
- Volunteers who have a negative urine drug screen.
- Female volunteers must have a negative pregnancy screen.
- Female volunteers practicing an acceptable method of birth control as judged by the investigator(s), such as condom with spermicide, diaphragm with spermicide, intrauterine device (IUD), or abstinence throughout the duration of the study; or of postmenopausal (no menses) status for at least 1 year; or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
Who cannot join
- Volunteers who report receiving any investigational drug within 28 days prior to Period I dosing.
- Volunteers who report any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease as determined by the clinical investigator(s).
- Volunteers whose clinical laboratory test values outside the accepted reference range and when confirmed on re-examination is deemed to be clinically significant.
- Volunteers who demonstrate a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
- Volunteers who report a history of allergic response(s) to propranolol or related drugs.
- Volunteers who report the use of any systemic prescription medication in the 14 days prior to Period I dosing.
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- Volunteers who report the use of any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to Period I dosing.
- Volunteers who report a history of clinically significant allergies including drug allergies.
- Volunteers who report a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).
- Volunteers who report a history of drug or alcohol addiction or abuse within the past year.
- Volunteers who demonstrate a positive drug abuse screen for this study prior to Period I dose administration.
- Volunteers who currently use tobacco products.
- Volunteers who report donating greater than 150 mL of blood within 28 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
- Volunteers who report donating plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study.
- Volunteers who demonstrate a positive pregnancy screen (females only).
- Volunteers who are currently pregnant or breastfeeding (females only).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Relative Bioavailability Study of 160 mg Propranolol Hydrochloride Extended Release Capsules Under Fasting Conditions
The purpose of this study is TO compare the relative bioavailability of Propranolol Hydrochloride Extended Release Capsules 160 mg (Actavis) with that of INDERAL® LA 160 mg Capsules (Wyeth Pharmaceuticals) following a single oral dose (1 x 160 mg) in healthy adult volunteers under fasting conditions.
Read the detailed description
Study Type: Interventional Study Design: Randomized, single dose, two-way crossover study under fasting conditions
Official Title: A Relative Bioavailability Study of 160 mg Propranolol Hydrochloride Extended Release Capsules Under Fasting Conditions
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
- Conditions
- Healthy
- Being tested
- Propranolol Hydrochloride Extended Release Capsules 160 mg, INDERAL® LA 160 mg Capsules, single dose
- Keywords
- Bioequivalence, Propranolol, Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propranolol Hydrochloride Extended Release Capsules 160 mgDrug
Also called Propranolol
A: Experimental Subjects received Actavis formulated products under fasting conditions
INDERAL® LA 160 mg Capsules, single doseDrug
Also called Propranolol
B: Active comparator Subjects received Wyeth Pharmaceuticals formulated products under fasting conditions
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Propranolol Hydrochloride Extended Release Capsules 160 mg, single dose Receives: Drug: Propranolol Hydrochloride Extended Release Capsules 160 mg |
| B | Active comparator | INDERAL® LA 160 mg Capsules, single dose Receives: Drug: INDERAL® LA 160 mg Capsules, single dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate and Extend of Absorption
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startApr 2005
- Primary completionApr 2005
- Study completionApr 2005
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.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James D. Carlson,, Pharm.D,, Principal investigator, PRACS Institute, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00865215
- Sponsor's protocol ID
- R05-1383
- Status last verified
- Aug 2010
- First submitted
- 18 Mar 2009
- Last updated
- 17 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Relative Bioavailability Study of 160 mg Propranolol Hydrochloride Extended Release Capsules Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT00865215
- Acronym / sponsor ID
- R05-1383
- Conditions
- Healthy
- Keywords
- Bioequivalence, Propranolol, Healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 19 Mar 2009 (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 relative bioavailability of Propranolol Hydrochloride Extended Release Capsules 160 mg (Actavis) with that of INDERAL® LA 160 mg Capsules (Wyeth Pharmaceuticals) following a single oral dose (1 x 160 mg) in healthy adult volunteers under fasting conditions.
Detailed description
Study Type: Interventional Study Design: Randomized, single dose, two-way crossover study under fasting conditions
Official Title: A Relative Bioavailability Study of 160 mg Propranolol Hydrochloride Extended Release Capsules Under Fasting Conditions
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Propranolol Hydrochloride Extended Release Capsules 160 mgPropranolol Hydrochloride Extended Release Capsules 160 mg, single dose |
| B | Active comparator | Drug: INDERAL® LA 160 mg Capsules, single doseINDERAL® LA 160 mg Capsules, single dose |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Volunteers who have been informed of the nature of the study and agree to read, review and sign the informed consent document prior to Period I dosing.
- Volunteers who have completed the screening process within 28 days prior to Period I dosing.
- Volunteers who are healthy adult men and women 18 to 50 years of age, inclusive, at the time of dosing.
- Volunteers who have a body mass index (BMI) between 18-32 kg/m2, inclusive, and weigh at least 110 lbs.
- Volunteers who are healthy as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems), vital sign assessments, 12-lead electrocardiogram (ECG), clinical laboratory assessments, and by general observations. Any abnormalities/deviations from the normal range that might be considered clinically relevant by the study physician and investigator will be evaluated for individual cases, documented in study files, and agreed upon by both the study physician and investigator prior to enrolling the volunteer in this study and for continued enrollment.
Key exclusion criteria (16 listed)
- Volunteers who report receiving any investigational drug within 28 days prior to Period I dosing.
- Volunteers who report any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease as determined by the clinical investigator(s).
- Volunteers whose clinical laboratory test values outside the accepted reference range and when confirmed on re-examination is deemed to be clinically significant.
- Volunteers who demonstrate a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
- Volunteers who report a history of allergic response(s) to propranolol or related drugs.
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 |
|---|---|---|
| Propranolol Hydrochloride Extended Release Capsules 160 mgAlso: PropranololA: Experimental Subjects received Actavis formulated products under fasting conditions | Drug | A |
| INDERAL® LA 160 mg Capsules, single doseAlso: PropranololB: Active comparator Subjects received Wyeth Pharmaceuticals formulated products under fasting conditions | Drug | B |
Primary outcome
Rate and Extend of Absorption
Time frame: 48 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 17 Aug 2010.
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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.
James D. Carlson,, Pharm.D, principal investigator
PRACS Institute, Ltd.
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 Propranolol Hydrochloride Extended Release Capsules 160 mg and INDERAL® LA 160 mg Capsules, single dose in people with Healthy, run by Actavis 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 8 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 17 Aug 2010. 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?
Rate and Extend of Absorption (time frame: 48 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 17 Aug 2010.