Clinical trial NCT00776542: Bioequivalence Study of Minocycline 100mg Tablets Under Fasting Conditions
Official title: Single Dose Two-Way Crossover Fasted Bioequivalence Study of Minocycline 100 mg Capsules in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: bioequivalence Minocycline Tablets
Lead sponsor: Ranbaxy Inc.
Sponsor class: INDUSTRY
First posted: 2008-10-21
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

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,

Eligibility 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.

Primary outcomes:
measure: Bioequivalence
Secondary outcomes:
Other outcomes:
Locations:
city: Chapell Hill
country: United States
facility: AII pharma
state: North Carolina
Study officials:
References: