HealthyPhase 1NCT00834873

Carvedilol (25 mg) in 24 Fed, Healthy, Adult Subjects

A Phase 1 study testing Carvedilol 25 mg tablets and COREG® 25 mg tablets in people with Healthy, run by Teva Pharmaceuticals USA 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 objective of this randomized, single-dose, two-way crossover evaluation is to compare the relative bioequivalence of a test carvedilol formulation (TEVA Pharmaceuticals USA) to and equivalent oral dose of the commercially available carvedilol (COREG®, SmithKline Beecham Pharmaceuticals) in a test population of 24… 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 25 mg tablets and COREG® 25 mg tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Dec 2001to Dec 2001
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Sex: Male of Female; similar proportions of each preferred.
Age: At least 18 years.
Weight: Minimum of 120 pounds and a BMI (body mass index) of less than 30.

Who cannot join

Subjects not complying with the above inclusion criteria must be excluded from the study.
In addition, any one of the conditions listed below will exclude a subject from the study.
History of treatment for alcoholism, substance abuse, or drug abuse within the past 24 months
History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness.
History of treatment for any gastrointestinal disorder within the past five (5) years.
History of, or presence of, asthma

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History of peripheral vascular disease
History of heart failure
History of pre-existing cardiac arrythmias associated with tachycardia
History of severe sensitivity to allergens, requiring urgent medical treatment.
Females who are pregnant or lactating
History of hypersensitivity to carvedilol, or any beta adrenergic blocking drug.
Conditions upon screening which might contraindicate or require that caution be used in the administration of carvedilol, including:
sitting systolic blood pressure below 100 mmHg, or diastolic pressure below 60 mmHg.
Heart rate less than 60 beats per minute after a 5-minute rest in a seated position.
Inability to read and/or sign the consent form.
Treatment with any other investigational drug during the four (4) weeks prior to the initial dosing for this study.
Subjects who smoke or use tobacco products or are currently using nicotine products (patches, gums,etc.) Ninety (90) days abstinence is required.
subjects who have donated blood within four (4) weeks prior to the initial dosing for this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Gateway Medical Research, Inc.
Saint Charles, Missouri, 63301

Other trials in United States

About this study

Official title: A Randomized, Two-Way Crossover, Single-Dose, Open Label Study to Evaluate the Relative Bioavailability of a Test Tablet Formulation of Carvedilol (25 mg), Compared to an Equivalent Dose of COREG® (SmithKline Beecham Pharmaceuticals) in 24 Fed, Healthy, Adult Subjects

Read the detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Conditions: Healthy
Being tested: Carvedilol 25 mg tablets, COREG® 25 mg tablets
Keywords: Bioequivalence, Healthy Subjects

What participants receive

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

Carvedilol 25 mg tabletsDrug
1 x 25 mg
COREG® 25 mg tabletsDrug
1 x 25 mg

Study groups in NCT00834873
Study group	Role	What they receive
Carvedilol	Experimental	Carvedilol 25 mg Tablet (test) dosed in first period followed by Coreg® 25 mg Tablet (reference) dosed in second period Receives: Drug: Carvedilol 25 mg tablets
Coreg®	Active comparator	Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period Receives: Drug: COREG® 25 mg tablets

What is being measured

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

Cmax - Maximum Observed Concentration - Carvedilol in Plasma
Bioequivalence based on Cmax
Measured: Blood samples collected over 60 hour period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Carvedilol in Plasma
Bioequivalence based on AUC0-inf
Measured: Blood samples collected over 60 hour period
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Carvedilol in Plasma
Bioequivalence based on AUC0-t
Measured: Blood samples collected over 60 hour period

Timeline

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

Dec 2001Dec 2001

First posted3 Feb 2009 (estimated)
Study startDec 2001
Primary completionDec 2001
Study completionDec 2001

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00834873
Sponsor's protocol ID: 01269
Status last verified: Aug 2024
First submitted: 30 Jan 2009
Last updated: 19 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Two-Way Crossover, Single-Dose, Open Label Study to Evaluate the Relative Bioavailability of a Test Tablet Formulation of Carvedilol (25 mg), Compared to an Equivalent Dose of COREG® (SmithKline Beecham Pharmaceuticals) in 24 Fed, Healthy, Adult Subjects
ClinicalTrials.gov ID: NCT00834873
Acronym / sponsor ID: 01269
Conditions: Healthy
Keywords: Bioequivalence, Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
Study start: Dec 2001
Primary completion: Dec 2001 (actual)
Study completion: Dec 2001 (actual)
First posted: 3 Feb 2009 (estimated)
Results: Posted 18 Aug 2009

Clinical summary

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

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Study design

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

Arm	Type	Receives
Carvedilol	Experimental	Drug: Carvedilol 25 mg tabletsCarvedilol 25 mg Tablet (test) dosed in first period followed by Coreg® 25 mg Tablet (reference) dosed in second period
Coreg®	Active comparator	Drug: COREG® 25 mg tabletsCoreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Sex: Male of Female; similar proportions of each preferred.
Age: At least 18 years.
Weight: Minimum of 120 pounds and a BMI (body mass index) of less than 30.

Key exclusion criteria (19 listed)

Subjects not complying with the above inclusion criteria must be excluded from the study.
In addition, any one of the conditions listed below will exclude a subject from the study.
History of treatment for alcoholism, substance abuse, or drug abuse within the past 24 months
History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness.
History of treatment for any gastrointestinal disorder within the past five (5) years.

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
Carvedilol 25 mg tablets1 x 25 mg	Drug	Carvedilol
COREG® 25 mg tablets1 x 25 mg	Drug	Coreg®

Primary outcome

Cmax - Maximum Observed Concentration - Carvedilol in Plasma
Time frame: Blood samples collected over 60 hour period
Bioequivalence based on Cmax
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Carvedilol in Plasma
Time frame: Blood samples collected over 60 hour period
Bioequivalence based on AUC0-inf
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Carvedilol in Plasma
Time frame: Blood samples collected over 60 hour period
Bioequivalence based on AUC0-t

Results and safety

Results posted to the registry on 18 Aug 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Carvedilol (Test) First	12	12
Coreg® (Reference) First	12	11

Primary outcome: Cmax - Maximum Observed Concentration - Carvedilol in Plasma

Time frame: Blood samples collected over 60 hour period. Mean (Standard Deviation). Unit: ng/mL

Measure	Carvedilol n = 23	Coreg® n = 23
Value	89.91 (40.86)	97.05 (49.61)

Carvedilol vs Coreg®: Test/Ref Ratio of LS Means x 100: 94.77 (90% CI 85.04 to 105.61)

Population analysed: Data from all subjects who completed the study were included in the statistical analysis.

Primary outcome: AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Carvedilol in Plasma

Time frame: Blood samples collected over 60 hour period. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Carvedilol n = 23	Coreg® n = 23
Value	467.57 (287.12)	490.16 (337.58)

Carvedilol vs Coreg®: Test/Ref Ratio of LS Means x 100: 96.23 (90% CI 90.59 to 102.23)

Population analysed: Data from all subjects who completed the study were included in the statistical analysis.

Primary outcome: AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Carvedilol in Plasma

Time frame: Blood samples collected over 60 hour period. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Carvedilol n = 23	Coreg® n = 23
Value	455.91 (284.99)	478.61 (336.07)

Carvedilol vs Coreg®: Test/Ref Ratio of LS Means x 100: 96.11 (90% CI 90.45 to 102.12)

Population analysed: Data from all subjects who completed the study were included in the statistical analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

M David Ayra, M.D. principal investigator

Gateway

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 Carvedilol 25 mg tablets and COREG® 25 mg tablets in people with Healthy, run by Teva Pharmaceuticals USA 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 3 inclusion and 19 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 19 Aug 2024. 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?

Yes. Results are posted in the registry (first posted 18 Aug 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Cmax - Maximum Observed Concentration - Carvedilol in Plasma (time frame: Blood samples collected over 60 hour period). The study lists 3 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 NCT00834873.

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 19 Aug 2024.