Bioequivaelnce Study of Doxycycline Monohydrate 100mg Tablets Under Fed Conditions

NCT00775918 | Completed DMC

• 1 other identifier: AAI-US-312
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Bioequivalence Doxycycline monohydrate 100mg tablets fed conditions

Outcome Measures

Primary Outcomes (1)

• Bioequivalence

Study Arms (2)

1

EXPERIMENTAL

Doxycycline monohydrate 100mg tablets of Ranbaxy

Drug: Doxycycline monohydrate 100mg tablets

2

ACTIVE COMPARATOR

Adoxa ® 100 mg tablets of Bradley Pharmaceuticals Inc

Drug: Doxycycline monohydrate 100mg tablets

Interventions

Doxycycline monohydrate 100mg tablets DRUG

Bioequiavelnce Doxycycline monohydrate 100mg tablets fed conditions

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead

Study Sites (1)

aaiPharma, Inc.

Chapel Hill, North Carolina, 27517, United States

Location

Related Links

• Related Info
• Related Info
• Related Info

MeSH Terms

Interventions

Doxycycline

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

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

Study Record Dates

• First Submitted: October 17, 2008
• First Posted: October 20, 2008
• Study Start: June 1, 2005
• Primary Completion: June 1, 2005
• Study Completion: August 1, 2005
• Last Updated: October 20, 2008

Record last verified: 2008-10

Locations

US (1)