Bioequivalence Study of Minocycline 100mg Tablets Under Fasting Conditions

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,

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.