NCT00864149

CompletedPhase 1

A Relative Bioavailability Study of Carvedilol 12.5 mg Table...

Actavis Inc.Source

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Other study identifiers

Sponsor study identifier

3166

Study Type

interventional

Actual enrollment (reported)

36

Locations

1 country

Sites

1

Timeline

Study Start

October 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

November 2005

Actual (reported)

Study Completion

November 2005

Actual (reported)

Brief Summary

To compare the rate and extent of absorption of carvedilol from a test formulation of Carvedilol 12.5 mg Tablets versus the reference Coreg® 12.5 mg Tablets under fed conditions.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 36 participants
Study completion date: November 2005
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
October 2005
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
November 2005
Actual (reported)
Study Completion
November 2005
Actual (reported)
First Submitted
March 17, 2009
Actual (reported)
First Posted
March 18, 2009
Actual (reported)

Last Updated: August 16, 2010
Status Verified: August 2010
Last Update Submitted: August 13, 2010

Conditions

Healthy

Keywords

BioequivalenceCarvedilolHealthy subjects

Outcome Measures

Primary Outcomes (1)

Rate and Extend of Absorption
36 hours

Study Arms (2)

A

EXPERIMENTAL

Carvedilol 12.5 mg Tablets, single dose

Drug: Carvedilol 12.5 mg Tablets, single dose

B

ACTIVE COMPARATOR

Coreg® 12.5 mg Tablets , single dose

Drug: Coreg® 12.5 mg Tablets , single dose

Interventions

Carvedilol 12.5 mg Tablets, single doseDrug

A: Experimental Subjects received Shasun Chemicals and Drugs Ltd. formulated products under fed conditions

Also known as: Carvedilol

A

Coreg® 12.5 mg Tablets , single doseDrug

B: Active comparator Subjects received GlaxoSmithKline, USA formulated products under fed conditions

Also known as:

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Non-smoking male or female with a minimum age of 18 years.
Body Mass Index (BMI = weight/heigh2) greater than or equal to 18.5 kg/m2 and less than or equal to 29.9 kg/m2

Sponsors & Collaborators

Actavis Inc.
Industrylead

Study Sites (1)

Biovail Contract Research (A Division of Biovail Corporation)

Toronto, Ontario, M1L 4S4 / M1L 4R6, Canada

MeSH Terms

Interventions

Carvedilol

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-Ring

Study Officials

Paul Y. Tam,, M.D
Biovail Contract Research
PRINCIPAL INVESTIGATOR

Enrollment

36 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

March 17, 2009

First Posted

March 18, 2009

Study Start

October 2005

Date type not reported

This date has not been verified as actual or estimated.

NCT00834795

Carvedilol 25 mg in 36 Fasted, Healthy, Adult Subjects

Phase 1Completed

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Carvedilol 25 mg Film-coated Tablets, Bioequivalence Study of Dr. Reddys Under Fed Conditions

Phase 1Completed

NCT01064154

Carvedilol 25 mg Film-coated Tablets, Bioequivalence Study of Dr. Reddys Under Fasting Conditions

Phase 1Completed

NCT00776113

Bioequivalence Study of Carvedilol 12.5mg Tablets Under Fasting Conditions

Not ApplicableCompleted

NCT00775619

Bioequivalence Study of Carvedilol 12.5mg Tablets Under Fed Conditions

Not ApplicableCompleted

NCT00870571

A Relative Bioavailability Study of Amlodipine Besylate 10 mg Tablets Tablets Under Fed Conditions

Phase 1Completed

Carvedilol

B

Normal findings in the physical examination, 12-lead ECG and vital signs (blood pressure between 106-140/66-90 mmHg, heart rate between 60-99 beats/minute, temperature between 35.8°C and 37.5°C)

Negative for drugs of abuse and nicotine.

Negative for hepatitis B-surface antigen, hepatitis C and HIV.

Female subjects: negative for pregnancy (as evaluated by serum ß-CG test).

No clinical laboratory values outside of the acceptable range as defined by BCR, unless the Principal Investigator decides that they are not clinically significant.

Female subjects who were surgically sterile for at least 6 months or post-menopausal for at least 1 year, or avoided pregnancy for at least 10 days before the study, during the study and up until 1 month after the end of the study.

Availability of the subject for the entire study period and willingness of the subject to adhere to protocol requirements, as evidenced by a signed ICF

You may not qualify if:

Known history of hypersensitivity to carvedilol (e.g. Coreg®) and/or related beta¬blockers such as propranolol (Inderal®, nadolol (Corgard®), labetalol (Trandate®, metoprolol (Lopressor®, Betaloc®, atenolol (Tenormin®, sotalol, timolol, pindolol, or acebutolol.
Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, liver or kidney disease, unless deemed not clinically significant by the Principal Investigator or Sub-investigator.
Presence of any significant physical or organ abnormality.
Any history or evidence of psychiatric or psychological disease (including depression) unless deemed not clinically significant by the Principal Investigator or Sub-investigator.
Known history of frequent headaches or migraines.
Known history of chronic bronchitis or any bronchospastic condition.
Any clinically significant illness during the 4 weeks before this study.
Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
Any history of severe allergic reaction (including drugs, food, insect bites, environmental allergens).
Significant or recent history of asthma (after 12 years of age).
Any subject with a history of drug abuse.
Any subject with a recent (less than 1 year) history of alcohol abuse.
Use of any prescription medication within 14 days preceding this study.
Use of any over-the-counter (OTC) cough and cold medication containing dextromethorphan within 14 days preceding this study.
Use of OTC medication within 7 days preceding this study (except for spermicidal/barrier contraceptive products).
+7 more criteria

Contact the study team to confirm eligibility.

Primary Completion

November 2005

Actual (reported)

Study Completion

November 2005

Actual (reported)

Last Updated

August 16, 2010

Record last verified: 2010-08

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

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Registry identifier: NCT00864149
Data provider: ClinicalTrials.gov
Source updated: 2010-08-16
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:18:15 UTC

Locations

CA(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

A

B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations