NCT00834873

Brief 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 adult individuals under fed conditions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Dec 2001

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2001

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 3, 2009

Completed
7 months until next milestone

Results Posted

Study results publicly available

August 18, 2009

Completed
Last Updated

August 19, 2024

Status Verified

August 1, 2024

Enrollment Period

Same day

First QC Date

January 30, 2009

Results QC Date

May 8, 2009

Last Update Submit

August 15, 2024

Conditions

Healthy

Keywords

BioequivalenceHealthy Subjects

Outcome Measures

Primary Outcomes (3)

  • Cmax - Maximum Observed Concentration - Carvedilol in Plasma

    Bioequivalence based on Cmax

    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

    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

    Blood samples collected over 60 hour period

Study Arms (2)

Carvedilol

EXPERIMENTAL

Carvedilol 25 mg Tablet (test) dosed in first period followed by Coreg® 25 mg Tablet (reference) dosed in second period

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

Drug: COREG® 25 mg tablets

Interventions

Carvedilol 25 mg tabletsDRUG

1 x 25 mg

Carvedilol
COREG® 25 mg tabletsDRUG

1 x 25 mg

Coreg®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gateway Medical Research, Inc.

Saint Charles, Missouri, 63301, United States

Location

MeSH Terms

Interventions

Carvedilol

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Manager, Biopharmaceutics
Organization
Teva Pharmaceuticals USA
clinicaltrialqueries@tevausa.com
1-866-384-5525

Study Officials

  • M David Ayra, M.D.

    Gateway

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

January 30, 2009

First Posted

February 3, 2009

Study Start

December 1, 2001

Primary Completion

December 1, 2001

Study Completion

December 1, 2001

Last Updated

August 19, 2024

Results First Posted

August 18, 2009

Record last verified: 2024-08

Locations

US(1)