Overview

Bioequivaelnce Study of Doxycycline Monohydrate 100mg Tablets Under Fed Conditions

Status:
Completed
Trial end date:
2005-08-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study was to determine the bioequivalence of Doxycycline monohydrate formulations after administration of single doses to normal healthy subjects under fed conditions. These data were to be evaluated statistically to determine if the products meet bioequivalence criteria.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Ranbaxy Laboratories Limited
Treatments:
Doxycycline
Criteria
Inclusion Criteria:

- a) Healthy male and female subjects of at least 18 years of age. b) Informed of the
nature of the study and given written informed consent. c). Have a body mass index
between 18 and 30 and weighing at least 110 pounds. d) In good health as determined by
lacking of clinically significant abnormalities in health assessments performed at
screening as judged by the physician.

Exclusion Criteria:

- a) Hypersensitivity to Doxycycline monohydrate (Adoxa®), or related compounds such as
tetracycline.

b) Any history of a clinical condition which might affect drug absorption, metabolism
or passage of drugs out of the body, e.g. sprue, celiac disease, Crohn's disease,
colitis, liver, kidney or thyroid conditions.

c) Recent history of mental illness, drug addiction, drug abuse or alcoholism. d)
Donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or
difficulty in donating blood.

e) Received an investigational drug within the 4 weeks prior to study dosing. f)
Currently taking any systemic prescription medication, except oral / cutaneous/
vaginal hormone 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 non-prescription
medication consumption reported will be reviewed by the investigator prior to dosing.
At the discretion of the investigator these volunteers may be enrolled if the
medication is not anticipated to alter study integrity.

g) Regular smoking of more than 5 cigarettes per week or the daily use of
nicotine-containing products beginning 3 months before the study medication
administration through the final evaluation.

h) If female, the subject is lactating or has a positive pregnancy test at screening
and prior to each of the two treatment periods. Females of child bearing potential
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 spermicide,
diaphragm with spermicide, IUD, vaginal spermicidal or 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.

i) Alcohol, grapefruit beverages or foods or caffeine beverages or foods beginning 24
hours before each study medication administration through each study confinement
period. Such restricted items include tea, coffee, iced tea, coke, Pepsi, mountain
dew, chocolate, brownies, etc.

j) Significant history or current evidence of chronic infectious disease, system
disorders or organ dysfunction k) Regular use of any drugs known to induce or inhibit
hepatic drug metabolism (e.g. barbiturates, carbamazepine, rifampin,
phenylhydantaoins, phenothiazines, cimetidine, Omeprazole, macrolides, imidazoles,
fluoroquinolines) within 30 days prior to study administration l) Positive test
results for HIV, hepatitis B surface antigen, hepatitis C antibodies, drugs of abuse,
or pregnancy at screening.