- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00775580
Bioequivalence Study of Atenolol 100mg Tablets Under Fasting Conditions
Single Dose Two-Way Crossover Fasted Bioequivalence Study of Atenolol 100 mg Capsules in Healthy Volunteers
Study Overview
Detailed Description
The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover , bioequivalence study on atenolol comparing atenolol 100mg tablets of Ranbaxy with Tenormin 100mg capsules in healthy, adult, human, subjects under fasting conditions.
A total of 36 non-smoking subjects (26 men and 10 women) were included in this study, of which 35 finished the study according to the protocol,
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
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Chapell Hill, North Carolina, United States, 27517
- aaiPharma, Inc. -AAI Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy subjects at least 18 years of age.
- Informed of the nature of the study and given written informed consent.
- Have a body weight within 15% of the appropriate range as defined in the 1983 Metropolitan Life Company tables weighing at least 110 pounds.
Exclusion Criteria:
- Hypersensitivity to Atenolol (Tenormin®) or related compounds such as propranolol (Inderal®).
- Conditions that affect the absorption, metabolism or passage of drugs out of the body, e.g., sprue, celiac disease, Crohn's disease, colitis, liver, kidney or thyroid conditions.
- Recent history (within one year) of mental illness, drug addiction, drug abuse or alcoholism.
- Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
- Received an investigational drug within the 4 weeks prior to study dosing.
- Currently taking any prescription medication, except for oral contraceptives, within the 7 days prior to study dosing or over-the-counter medication within 3 days of study dosing. This prohibition does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician. Any nonprescription medication consumption reported will be reviewed by the investigator(s) prior to dosing. At the discretion of the investigator(s), these volunteers may be enrolled if the medication is not anticipated to alter study integrity.
- Regular smoking of more than 5 cigarettes daily or the daily use of nicotine-containing products beginning 3 months before study medication administration through the final evaluation.
- If female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the treatment periods. Females must use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed. Medically acceptable methods of contraception that may be used by the subject and/or her partner are: oral contraceptives/patches, progestin injection or implants, condom with spermacide, diaphragm with spermacide, IUD, vaginal spermicidal/hormonal suppository, surgical sterilization of themselves or their partner(s) or abstinence. Females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.
Study Plan
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
atenolol 100 mg Capsules of Ranbaxy
|
|
ACTIVE_COMPARATOR: 2
Tenormin 100mg capsules
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Bioequivalence
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Sympatholytics
- Adrenergic beta-1 Receptor Antagonists
- Atenolol
Other Study ID Numbers
- AAI-US-310
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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