- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00777413
Bioequivalecne Study of Minocycline 100mg Tablets Under Fed Conditions
Single Dose Two-Way Crossover Fed Bioequivalence Study of Minocycline 100 mg Capsules in Healthy Volunteers
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Chapell Hill, North Carolina, United States, 27514
- AII pharma
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Minocycline 100 mg tablets of Ranbaxy
|
|
Active Comparator: 2
Minocin 100mg tablets
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Bioequivalence
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAI-US-135
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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