- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00649480
Fed Study of Balsalazide Disodium Capsules 750 mg and Colazal® Capsules 750 mg
April 22, 2024 updated by: Mylan Pharmaceuticals Inc
Single-Dose Fed Bioequivalence Study of Balsalazide Disodium Capsules (750 mg; Mylan) and Colazal® Capsules (750 mg; Salix) in Healthy Volunteers
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Dakota
-
Fargo, North Dakota, United States, 58104
- PRACS Institute Ltd. - Cetero Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
BALSALAZIDE DISODIUM CAPSULES, 750 MG
|
3x750mg, single dose fed
|
Active Comparator: 2
COLAZAL® Capsules 750 mg
|
3x750mg, single dose fed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Bioequivalence
Time Frame: within 30 days
|
within 30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alan K Copa, Pharm.D., PRACS Institute, Ltd.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
February 1, 2007
Study Completion (Actual)
February 1, 2007
Study Registration Dates
First Submitted
March 30, 2008
First Submitted That Met QC Criteria
March 31, 2008
First Posted (Estimated)
April 1, 2008
Study Record Updates
Last Update Posted (Actual)
April 24, 2024
Last Update Submitted That Met QC Criteria
April 22, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BALS-06128
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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