Carvedilol 25 mg in 36 Fasted, Healthy, Adult Subjects
This study has been completed.
Sponsor:
Teva Pharmaceuticals USA
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00834795
First received: January 30, 2009
Last updated: September 11, 2009
Last verified: September 2009
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Carvedilol 25 mg tablets Drug: COREG® 25 mg tablets |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label |
| 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 |
Resource links provided by NLM:
Further study details as provided by Teva Pharmaceuticals USA:
Primary Outcome Measures:
- Cmax - Maximum Observed Concentration - Carvedilol in Plasma [ Time Frame: Blood samples collected over 60 hour period ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 36 |
| Study Start Date: | December 2001 |
| Study Completion Date: | December 2001 |
| Primary Completion Date: | December 2001 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Carvedilol
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
1 x 25 mg
|
|
Active Comparator: Coreg®
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
1 x 25 mg
|
Detailed Description:
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00834795
Locations
| United States, Missouri | |
| Gateway Medical Research, Inc. | |
| St. Charles, Missouri, United States, 63301 | |
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
| Principal Investigator: | M David Ayra, M.D. | Cetero Research, San Antonio |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00834795 History of Changes |
| Other Study ID Numbers: | 01268 |
| Study First Received: | January 30, 2009 |
| Results First Received: | May 8, 2009 |
| Last Updated: | September 11, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Teva Pharmaceuticals USA:
|
Bioequivalence Healthy Subjects |
Additional relevant MeSH terms:
|
Carvedilol Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Physiological Effects of Drugs Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Vasodilator Agents Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists |
ClinicalTrials.gov processed this record on May 23, 2013