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Bioequivalecne Study of Minocycline 100mg Tablets Under Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Ranbaxy Inc.
ClinicalTrials.gov Identifier:
NCT00777413
First received: October 20, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

The purpose of this study was to determine the bioequivalence of Minocycline 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: Minocycline 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 Minocycline 100 mg Capsules 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: 24
Study Start Date: November 2002
Study Completion Date: January 2003
Primary Completion Date: November 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Minocycline 100 mg tablets of Ranbaxy
Drug: Minocycline 100mg Tablets
Active Comparator: 2
Minocin 100mg tablets
Drug: Minocycline 100mg Tablets

Detailed Description:

The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover , bioequivalence study on minocycline comparing minocycline 100mg tablets of Ranbaxy with Minocin 100mg capsules of in healthy, adult, human, subjects under fed conditions.

A total of 24 non-smoking subjects (17 men and 7 women) were included in this study, of which 24 finished the study according to the protocol.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • a) Healthy males and females between 18 and 45 years of age inclusive. b) Informed of the nature of the study and given written informed consent. c). Have a body weight within 15 % of the appropriate range as defined in the 1983 Metropolitan Life Company tables and weighing at least 100 lbs.

Exclusion Criteria:

  • a) Hypersensitivity to Minocycline (Minocin®), or other antibiotics. b) Any history of a clinical condition which might affect drug absorption, metabolism or excretion.

    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 prescription medication, except oral contraceptives, within the 7 days pr/or to study dosing or over-the-counter medication within 3 days of study dosing. This prohibitior does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physic/an2 g) Tobacco use (>5 cigarettes per day) in the 3 months prior to study dosing. 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, progestin injection' or implants, condom with spermacide, diaphragm with spermacide, IUD, vaginal spermicidal suppository, surgical Sterilization of their partner(s) or abstinence. Females taking oral Contraceptives must . have taken them consistently for at least three months prior to receiving study medication.

  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: NCT00777413

Locations
United States, North Carolina
AII pharma
Chapell Hill, North Carolina, United States, 27514
Sponsors and Collaborators
Ranbaxy Laboratories Limited
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Tausif Monif, Ranbaxy Research labs
ClinicalTrials.gov Identifier: NCT00777413     History of Changes
Other Study ID Numbers: AAI-US-135
Study First Received: October 20, 2008
Last Updated: October 20, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Ranbaxy Inc.:
Bioequiavlence Minocycline Tablets

Additional relevant MeSH terms:
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014