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Trial record 12 of 116 for:    Atenolol

Bioequivalence Study of Atenolol 100mg Tablets Under Fasting Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00775580
Recruitment Status : Completed
First Posted : October 20, 2008
Last Update Posted : October 20, 2008
Information provided by:
Ranbaxy Inc.

Brief Summary:
The purpose of this study was to determine the bioequivalence of atenolol formulations after administration of single doses to normal healthy subjects under fasted conditions. These data were to be evaluated statistically to determine if the products meet bioequivalence criteria.

Condition or disease Intervention/treatment Phase
Healthy Drug: Atenolol 100mg Tablets Not Applicable

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,

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Single Dose Two-Way Crossover Fasted Bioequivalence Study of Atenolol 100 mg Capsules in Healthy Volunteers
Study Start Date : May 2005
Actual Primary Completion Date : May 2005
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Atenolol

Arm Intervention/treatment
Experimental: 1
atenolol 100 mg Capsules of Ranbaxy
Drug: Atenolol 100mg Tablets
Active Comparator: 2
Tenormin 100mg capsules
Drug: Atenolol 100mg Tablets

Primary Outcome Measures :
  1. Bioequivalence

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Healthy subjects at least 18 years of age.
  2. Informed of the nature of the study and given written informed consent.
  3. 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:

  1. Hypersensitivity to Atenolol (Tenormin®) or related compounds such as propranolol (Inderal®).
  2. 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.
  3. Recent history (within one year) of mental illness, drug addiction, drug abuse or alcoholism.
  4. Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood.
  5. Received an investigational drug within the 4 weeks prior to study dosing.
  6. 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.
  7. 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.
  8. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00775580

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United States, North Carolina
aaiPharma, Inc. -AAI Clinic
Chapell Hill, North Carolina, United States, 27517
Sponsors and Collaborators
Ranbaxy Laboratories Limited

Additional Information:
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Responsible Party: Dr. Tausif Monif, Ranbaxy Research Laboratories Identifier: NCT00775580     History of Changes
Other Study ID Numbers: AAI-US-310
First Posted: October 20, 2008    Key Record Dates
Last Update Posted: October 20, 2008
Last Verified: October 2008
Keywords provided by Ranbaxy Inc.:
bioequivalence Atenolol Tablets
Additional relevant MeSH terms:
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Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action