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Bioequivalence Study of Minocycline 100mg Tablets Under Fasting Conditions

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ClinicalTrials.gov Identifier: NCT00776542
Recruitment Status : Completed
First Posted : October 21, 2008
Last Update Posted : October 21, 2008
Sponsor:
Information provided by:
Ranbaxy Inc.

Study Description
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Brief Summary:
The purpose of this study was to determine the bioequivalence of Minocycline 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Minocycline 100mg Tablets Not Applicable

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 pharmaceuticals inc with Minocin 100mg capsules of in healthy, adult, human, subjects under fasting conditions.

A total of 28 non-smoking subjects (16 men and 12 women) were included in this study, of which 28 finished the study according to the protocol,

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Single Dose Two-Way Crossover Fasted Bioequivalence Study of Minocycline 100 mg Capsules in Healthy Volunteers
Study Start Date : October 2002
Actual Primary Completion Date : November 2002
Actual Study Completion Date : January 2003

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Minocycline 100 mg tablets of ranbaxy
 Drug: Minocycline 100mg Tablets
Active Comparator: 2
Minocin 100mg tablets
 Drug: Minocycline 100mg Tablets


Outcome Measures
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Primary Outcome Measures :
  1. Bioequivalence

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males and females between 18 and 45 years of age inclusive.
  • Informed o'f 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 and weighing at least 100 lbs.

Exclusion Criteria:

  • Hypersensitivity to Minocycline (Minocin®), or other antibiotics.
  • Any history of a clinical condition which might affect drug absorption, metabolism or excretion.
  • Recent history 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 oral contraceptives, within the 7 days pr/or to study dosing or over-the-counter medication within 3 days of study dosing. This prohibitor~ does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physic/an2
  • Tobacco use (>5 cigarettes per day) in the 3 months prior to study dosing.
  • 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 spermicide, diaphragm with spermicide, 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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00776542


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

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Responsible Party: Dr. Tausif Monif, Ranbaxy Research Laboratories
ClinicalTrials.gov Identifier: NCT00776542    
Other Study ID Numbers: AAI-US-134
First Posted: October 21, 2008    Key Record Dates
Last Update Posted: October 21, 2008
Last Verified: October 2008
Keywords provided by Ranbaxy Inc.:
bioequivalence Minocycline Tablets
Additional relevant MeSH terms:
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Minocycline
Anti-Bacterial Agents
Anti-Infective Agents