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

Mylan

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: BALSALAZIDE DISODIUM CAPSULES, 750 MG

Drug: COLAZAL® Capsules 750 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00649480

BALS-06128

Details and patient eligibility

About

The objective of this study was to investigate the bioequivalence of Mylan balsalazide disodium 750 mg capsules to Salix Colazal® 750 mg capsules following a single, oral 2250 mg (3 x 750 mg) dose administration under fed conditions.

Full description

This open-label, single dose, randomized, two-period, two-treatment, two-sequence, crossover study was conducted to investigate the bioequivalence of two formulations of balsalazide disodium 750 mg capsules under non-fasting conditions. The study was conducted with 60 (60 completing) healthy adults in accordance with Protocol No. BALS-06128 (Version 22 December 2006). In each study period, a single, oral 2250 mg dose (3 x 750 mg capsules) was administered to all subjects following an overnight fast of at least 10 hours. The test formulation was Mylan Pharmaceuticals Inc.'s Balsalazide Disodium Capsules, 750 mg and the reference formulation was Colazal® 750 mg capsules (manufactured for Salix Pharmaceuticals, Inc.). The subjects received the test product in one study period and the reference product in the other study period. Drug administration occurred according to the dosing randomization schedule (see Appendix 16.1.7). There was a 7-day washout interval between treatments.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Age:18 years and older
Sex: Male and/or non-pregnant, non-lactating female
Women of childbearing potential had a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 21 days prior to the start of the study and on the evening prior to each dose administration An additional serum (β-HCG) pregnancy test was performed upon completion of the study
Women of childbearing potential were required to practice abstinence or use an acceptable form of contraception throughout the duration of the study No hormonal contraceptives or hormonal replacement therapies were permitted in this study Acceptable forms of contraception included 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 sterilization
Women were not considered of childbearing potential if one of the following was reported and documented on the medical history
postmenopausal with an absence of menses for at least one (1) year or
bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months or
total hysterectomy
During the course of the study from study screen until study exit including the washout period all men and women of childbearing potential must use a spermicide containing barrier method of contraception in addition to their current contraceptive method
Weight:At least(132 lbs) for men and(106 lbs) for women with all subjects having a Body Mass Index less than or equal to 30 but greater than or equal to 19
All subjects were judged normal and healthy during a pre-study medical evaluation (physical examination laboratory evaluation Hepatitis B and Hepatitis C tests HIV test 12-lead ECG and urine drug screen including amphetamine barbiturates benzodiazepines cannabinoid cocaine opiates phencyclidine and methadone) performed within 21 days of the initial dose of study medication

Exclusion criteria

Institutionalized subjects were not used
Use of any tobacco-containing products within 1 year of the start of the study
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
A positive test for any drug included in the urine drug screen
History of drug and or alcohol abuse
Use of any prescription or over-the-counter medications within the 14 days prior to the initial dose of study medication
Use of any hormonal contraceptives or hormone replacement therapy within 3 months prior to study medication dosing
Use of any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication
History of any significant cardiovascular hepatic renal pulmonary hematologic gastrointestinal endocrine immunologic dermatologic or neurologic disease
Acute illness at the time of either the pre-study medical evaluation or dosing
A positive HIV hepatitis B or hepatitis C test
Abnormal and clinically significant laboratory test results
Clinically significant deviation from the Guide to Clinically Relevant
Abnormal and clinically relevant ECG tracing
Donation or loss of a significant volume of blood or plasma (> 450 mL) within 28 days prior to the initial dose of study medication
Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication
Allergy or hypersensitivity to balsalazide disodium salicylates or other related products
History of difficulties in swallowing or any gastrointestinal disease which could affect the drug absorption
Consumption of grapefruit or grapefruit containing products within 7 days of drug administration