Fasting Study of Balsalazide Disodium Capsules 750 mg and Colazal® Capsules 750 mg

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to investigate the bioequivalence of Mylan balsalazide disodium 750 mg capsules and Salix Colazal® 750 mg capsules following a single, oral 2250 mg (3 x 750 mg) dose administration under fasting conditions.

Official Title
-----------------
Single-Dose Fasting In Vivo Bioequivalence Study of Balsalazide Disodium Capsules (750 mg; Mylan) and Colazal® Capsules (750 mg; Salix) in Healthy Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Balsalazide Disodium Capsules 750 mg
* Drug: Colazal® Capsules 750 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and non-pregnant, non-lactating female Women of childbearing potential must have negative serum (Beta HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening prior to each dose administration. If dosing is scheduled on Sunday or Monday, the HCG pregnancy test should be given within 48 hours prior to dosing of each study period. An additional serum (Beta HCG) pregnancy test will be performed upon completion of the study. Women of childbearing potential must practice abstinence or be using an acceptable form of contraception throughout the duration of the study. Acceptable forms of contraception include the following: intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or barrier methods containing or used in conjunction with a spermicidal agent, or surgical sterility (tubal ligation, oophorectomy or hysterectomy) or postmenopausal accompanied with a documented postmenopausal course of at least one year. During the course of the study, from study screen until study exit including the washout period, women of childbearing potential must use a spermicide containing barrier method of contraception in addition to their current contraceptive device. This advice should be documented in the informed consent form. 3. Weight: At least 60 kg (132 lbs) for man and 48 kg (106 lbs) for women and within 15% of Ideal Body Weight (IBW), as referenced by the Table of Desirable Weights of Adults Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS). 4. All subjects should be judged normal and healthy during a pre-study medical evaluation (physical examination, laboratory evaluation, 12-lead ECG, hepatitis B and hepatitis C tests, HIV test, and urine drug screen including amphetamine, barbiturates, benzodiazepine, cannabinoid, cocaine, opiates, phencyclidine, and methadone) performed within 14 days of the initial dose of study medication. Exclusion Criteria: 1. Institutionalized subjects will not be used. 2. Social Habits: Use of any tobacco products. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication. Ingestion of any vitamins or herbal products within 7 days prior to the initial dose of the study medication. Any recent, significant change in dietary or exercise habits. 3. Medications: Use of any medication within the 14 days prior to the initial dose of study medication. Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication. Use of hormonal contraceptives and hormonal replacement therapy within three months prior to the initial dose of study medication. 4. Diseases: History of any significant chronic disease and/or hepatitis. History of drug and/or alcohol abuse. Acute illness at the time of either the pre-study medical evaluation or dosing. Positive HIV, Hepatitis B, or Hepatitis C test. 5. Abnormal and clinically significant laboratory test results: Clinically significant deviation from the Guide to Clinically Relevant Abnormalities (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PROTOCOLS). Abnormal and clinically relevant ECG tracing. 6. Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication. 7. Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication. 8. Allergy or hypersensitivity to balsalazide disodium, salicylates or other related products. 9. History of difficulties in swallowing, or any gastrointestinal disease which could affect the drug absorption. 10. Consumption of grapefruit or grapefruit containing products within 7 days of drug administration.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Balsalazide Disodium Capsules 750 mg | Drug: Balsalazide Disodium Capsules 750 mg<br>* 3x750mg, single dose fasting<br>|
| Active Comparator: 2<br>Colazal® Capsules 750 mg | Drug: Colazal® Capsules 750 mg<br>* 3x750mg, single dose fasting<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence |  | within 30 days |