Clinical trial NCT00834795: Carvedilol 25 mg in 36 Fasted, Healthy, Adult Subjects
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 36 Fasted, Healthy, Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Bioequivalence
Healthy Subjects
Lead sponsor: Teva Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2009-02-03
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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 36 adult individuals under fasting conditions.

Detailed description: Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: Cmax - Maximum Observed Concentration - Carvedilol in Plasma
timeFrame: Blood samples collected over 60 hour period
measure: AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - Carvedilol in Plasma
timeFrame: Blood samples collected over 60 hour period
measure: AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Carvedilol in Plasma
timeFrame: Blood samples collected over 60 hour period
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Charles
country: United States
facility: Gateway Medical Research, Inc.
state: Missouri
Study officials:
affiliation: Cetero Research, San Antonio
name: M David Ayra, M.D.
role: PRINCIPAL_INVESTIGATOR
References: