Bioequivaelnce Study of Doxycycline Monohydrate 100mg Tablets Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Ranbaxy Inc.
ClinicalTrials.gov Identifier:
NCT00775918
First received: October 17, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Healthy
Drug: Doxycycline monohydrate 100mg tablets

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Single Dose Two-Way Crossover Fed Bioequivalence Study of Doxycycline Monohydrate 100 mg Tablets in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Ranbaxy Inc.:

Primary Outcome Measures:
  • Bioequivalence [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: June 2005
Study Completion Date: August 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Doxycycline monohydrate 100mg tablets of Ranbaxy
Drug: Doxycycline monohydrate 100mg tablets
Bioequiavelnce Doxycycline monohydrate 100mg tablets fed conditions
Active Comparator: 2
Adoxa ® 100 mg tablets of Bradley Pharmaceuticals Inc
Drug: Doxycycline monohydrate 100mg tablets
Bioequiavelnce Doxycycline monohydrate 100mg tablets fed conditions

Detailed Description:

The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover , bioequivalence study on Doxycycline monohydrate comparing Doxycycline monohydrate 100mg tablets of Ranbaxy Pharmaceuticals Inc with Adoxa ® 100 mg tablets of Bradley Pharmaceuticals Inc. in healthy, adult, human, subjects under fed conditions.

A total of 32 non-smoking subjects (21 men and 11 women) were included in this study, of which 32 finished the study according to the protocol.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00775918

Locations
United States, North Carolina
aaiPharma, Inc.
Chapel Hill, North Carolina, United States, 27517
Sponsors and Collaborators
Ranbaxy Laboratories Limited
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Tausif Monif, Ranbaxy Laboratories Limited
ClinicalTrials.gov Identifier: NCT00775918     History of Changes
Other Study ID Numbers: AAI-US-312
Study First Received: October 17, 2008
Last Updated: October 17, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Ranbaxy Inc.:
Bioequivalence Doxycycline monohydrate 100mg tablets fed conditions

Additional relevant MeSH terms:
Doxycycline
Doxycycline hyclate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on July 29, 2014