Bioequivalecne Study of Minocycline 100mg Tablets Under Fed Conditions
Information source: Ranbaxy Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Minocycline 100mg Tablets (Drug)
Phase: N/A
Status: Completed
Sponsored by: Ranbaxy Laboratories Limited
Summary
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.
Clinical Details
Official title: Single Dose Two-Way Crossover Fed Bioequivalence Study of Minocycline 100 mg Capsules in Healthy Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Bioequivalence
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
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Both.
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 (MinocinĀ®), 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.
Locations and Contacts
AII pharma, Chapell Hill, North Carolina 27514, United States
Additional Information
Starting date: November 2002
Last updated: October 20, 2008
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