NCT00775580

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started May 2005

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 20, 2008

Completed
Last Updated

October 20, 2008

Status Verified

October 1, 2008

Enrollment Period

Same day

First QC Date

October 16, 2008

Last Update Submit

October 17, 2008

Conditions

Healthy

Keywords

bioequivalence Atenolol Tablets

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence

Study Arms (2)

1

EXPERIMENTAL

atenolol 100 mg Capsules of Ranbaxy

Drug: Atenolol 100mg Tablets

2

ACTIVE COMPARATOR

Tenormin 100mg capsules

Drug: Atenolol 100mg Tablets

Interventions

Atenolol 100mg TabletsDRUG
12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

aaiPharma, Inc. -AAI Clinic

Chapell Hill, North Carolina, 27517, United States

Location

Related Links

MeSH Terms

Interventions

Atenolol

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 16, 2008

First Posted

October 20, 2008

Study Start

May 1, 2005

Primary Completion

May 1, 2005

Study Completion

July 1, 2005

Last Updated

October 20, 2008

Record last verified: 2008-10

Locations

US(1)