Carvedilol 25 mg in 36 Fasted, Healthy, Adult Subjects

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 36

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Carvedilol	Carvedilol 25 mg tablets	Carvedilol 25 mg Tablet (test) dosed in first period followed by Coreg® 25 mg Tablet (reference) dosed in second period
Coreg®	COREG® 25 mg tablets	Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period

Primary Outcome Measures

Name	Time	Method
Cmax - Maximum Observed Concentration - Carvedilol in Plasma	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	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	Blood samples collected over 60 hour period	Bioequivalence based on AUC0-t