HealthyPhase 1NCT01064154
Carvedilol 25 mg Film-coated Tablets, Bioequivalence Study of Dr. Reddys Under Fasting Conditions
A Phase 1 study testing Carvedilol in people with Healthy, run by Dr. Reddy's Laboratories Limited.
Trial summary
Carvedilol 25 mg Film-coated Tablets, Bioequivalence Study Of Dr. Reddys Under Fasting 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?
- Carvedilol
- 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
- May 2002to May 2002
- 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 this study will be members of the community at large. The recruitment advertisements may be done using different media (e.g. radio, newspaper, Anapharm Inc. Website, Anapharm Inc. volunteers' data base). Subjects must meet all of the following criteria in order to be included in the study:
- Subjects will be females and/or males, smokers and non-smokers, 18 years of age \& older.
- Female subjects will be post-menopausal/surgically sterilized.
- Post-menopausal status is defined as absence of menses for the past 12 months or hysterectomy with bilateral oophorectomy at least 6 months ago.
- Sterile status is defined as hysterectomy, bilateral oophorectomy or tubal ligation at least 6 months ago.
Who cannot join
- Subjects to whom any of the following applies will be excluded from the study:
- Clinically significant illnesses/surgery within 4 weeks prior to the administration of study medication.
- Any clinically significant abnormality found during medical screening.
- Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study.
- Abnormal laboratory tests judged clinically significant.
- Subjects with a clinically significant history of second- or third-degree AV block, sick sinus syndrome or severe bradycardia or in patients with cardiogenic shock who have decompensated heart failure.
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- Subjects with history of hepatic failure.
- Presence or history of liver disease, cardiovascular disease, diabetes, hyperthyroidism aDd peripheral vascular disease.
- Positive urine drug screen or positive testing for hepatitis B, hepatitis C or HIV at screening.
- ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure <ll0 or over 140 mmHg, or diastolic blood pressure <70 or over 90 mmHg; or heart rate <60 or over 100 bpm) at screening.
- Subjects with BMI ≥30.0.
- History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than fourteen units of alcohol per week (1 Unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%).
- History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year of the screening visit.
- Any food allergy, intolerance, restriction or special diet that, in the opinion of the medical subinvestigator, contraindicates the subject's participation in this study.
- History of allergic reactions to carvedilol or other beta-blocking agents (e.g. propranolol, labetalol, acebutolol, atenolol, esmolol, metoprolol, oxprenolol, timolol, pindolol, betaxolol, levobunolol and nadolol).
- History of pulmonary or bronchospastic disease (including asthma).
- Subjects with pheochromocytoma.
- History of allergic reactions to heparin.
- Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin,ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine), use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
- Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (including natural products, vitamins, garlic as supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.
- Subjects who have had a depot injection or an implant of any drug 3 months prior to administration of study medication.
- Donation of plasma (500 mL) within 7 days. Donation or loss of whole blood prior to administration of the study medication as follows:
- less than 300 mL of whole blood within 30 days or
- 300 mL to 500 mL of whole blood within 45 days or
- more than 500 mL of whole blood within 56 days.
- Smoking more than 25 cigarettes per day.
- Subjects who have consumed food or beverages containing grapefruit (e.g. fresh, canned,or frozen) within 7 days prior to administration of the study medication.
- Additional exclusion criteria for females only:
- Breast-feeding subjects.
About this study
Official title: Randomized,2-way Crossover, Bioequivalence Study of Carvedilol 25 mg Film-coated Tablets and COREG® 25 mg Film-coated Tablets Administered as 1 x 25 mg Film-coated Tablet in Healthy Subjects Under Fasting Conditions
Carvedilol 25 mg Film-coated Tablets, Bioequivalence Study Of Dr. Reddys Under Fasting Conditions
Read the detailed description
A Randomized,two-way Crossover, Bioequivalence Study of Carvedilol 25 mg Film-coated Tablets and COREG® 25 mg Film-coated Tablets Administered as 1 x 25 mg Film-coated Tablet in Healthy Subjects Under Fasting Conditions.
Treatment Duration: Single dose of the two treatments (A, B) in two different occasions, separated by a washout period of 7 days.
- Conditions
- Healthy
- Being tested
- Carvedilol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarvedilolDrug
Also called Coreg Tablets 25 mg
Carvedilol Tablets 25 mg
| Study group | Role | What they receive |
|---|---|---|
| Carvedilol | Experimental | Carvedilol Tablets 25 mg of Dr Reddys Laboratories Limited Receives: Drug: Carvedilol |
| Coreg | Active comparator | Coreg Tablets 25 mg of GlaxoSmithKline Receives: Drug: Carvedilol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carvedilol Tablets, 25 mg Bioequivalence Study Of Dr Reddys under fasting condition
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2010 (estimated)
- Study startMay 2002
- Primary completionMay 2002
- Study completionMay 2002
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eric Bircell, MD, Principal investigator, Anapharm Inc, Canada, GIV 2K8
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01064154
- Sponsor's protocol ID
- 02117
- Status last verified
- Feb 2010
- First submitted
- 4 Feb 2010
- Last updated
- 8 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized,2-way Crossover, Bioequivalence Study of Carvedilol 25 mg Film-coated Tablets and COREG® 25 mg Film-coated Tablets Administered as 1 x 25 mg Film-coated Tablet in Healthy Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT01064154
- Acronym / sponsor ID
- 02117
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Primary completion
- May 2002 (actual)
- Study completion
- May 2002 (actual)
- First posted
- 8 Feb 2010 (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.
Carvedilol 25 mg Film-coated Tablets, Bioequivalence Study Of Dr. Reddys Under Fasting Conditions
Detailed description
A Randomized,two-way Crossover, Bioequivalence Study of Carvedilol 25 mg Film-coated Tablets and COREG® 25 mg Film-coated Tablets Administered as 1 x 25 mg Film-coated Tablet in Healthy Subjects Under Fasting Conditions.
Treatment Duration: Single dose of the two treatments (A, B) in two different occasions, separated by a washout period of 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carvedilol | Experimental | Drug: CarvedilolCarvedilol Tablets 25 mg of Dr Reddys Laboratories Limited |
| Coreg | Active comparator | Drug: CarvedilolCoreg Tablets 25 mg of GlaxoSmithKline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may be done using different media (e.g. radio, newspaper, Anapharm Inc. Website, Anapharm Inc. volunteers' data base). Subjects must meet all of the following criteria in order to be included in the study:
- Subjects will be females and/or males, smokers and non-smokers, 18 years of age \& older.
- Female subjects will be post-menopausal/surgically sterilized.
Key exclusion criteria (29 listed)
- Clinically significant illnesses/surgery within 4 weeks prior to the administration of study medication.
- Any clinically significant abnormality found during medical screening.
- Any reason which, in the opinion of the medical subinvestigator, would prevent the subject from participating in the study.
- Abnormal laboratory tests judged clinically significant.
- Subjects with a clinically significant history of second- or third-degree AV block, sick sinus syndrome or severe bradycardia or in patients with cardiogenic shock who have decompensated heart failure.
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 |
|---|---|---|
| CarvedilolAlso: Coreg Tablets 25 mgCarvedilol Tablets 25 mg | Drug | Carvedilol, Coreg |
Primary outcome
Carvedilol Tablets, 25 mg Bioequivalence Study Of Dr Reddys under fasting condition
Time frame: 4 months
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 8 Feb 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.
Eric Bircell, MD principal investigator
Anapharm Inc, Canada, GIV 2K8
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Carvedilol in people with Healthy, run by Dr. Reddy's Laboratories Limited.
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 5 inclusion and 29 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 8 Feb 2010. 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?
Carvedilol Tablets, 25 mg Bioequivalence Study Of Dr Reddys under fasting condition (time frame: 4 months). 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 8 Feb 2010.