HealthyPhase 1NCT00649480
Fed Study of Balsalazide Disodium Capsules 750 mg and Colazal® Capsules 750 mg
A Phase 1 study testing BALSALAZIDE DISODIUM CAPSULES, 750 MG and COLAZAL® Capsules 750 mg in people with Healthy, run by Mylan Pharmaceuticals Inc at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BALSALAZIDE DISODIUM CAPSULES, 750 MG and COLAZAL® Capsules 750 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Feb 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
PRACS Institute Ltd. - Cetero Research
Fargo, North Dakota, 58104
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- BALSALAZIDE DISODIUM CAPSULES, 750 MG, COLAZAL® Capsules 750 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BALSALAZIDE DISODIUM CAPSULES, 750 MGDrug
3x750mg, single dose fed
COLAZAL® Capsules 750 mgDrug
3x750mg, single dose fed
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | BALSALAZIDE DISODIUM CAPSULES, 750 MG Receives: Drug: BALSALAZIDE DISODIUM CAPSULES, 750 MG |
| 2 | Active comparator | COLAZAL® Capsules 750 mg Receives: Drug: COLAZAL® Capsules 750 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence
Measured: within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startJan 2007
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylan Pharmaceuticals Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alan K Copa, Pharm.D., Principal investigator, PRACS Institute, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00649480
- Sponsor's protocol ID
- BALS-06128
- Status last verified
- Apr 2024
- First submitted
- 30 Mar 2008
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Dose Fed Bioequivalence Study of Balsalazide Disodium Capsules (750 mg; Mylan) and Colazal® Capsules (750 mg; Salix) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00649480
- Acronym / sponsor ID
- BALS-06128
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mylan Pharmaceuticals IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 1 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: BALSALAZIDE DISODIUM CAPSULES, 750 MGBALSALAZIDE DISODIUM CAPSULES, 750 MG |
| 2 | Active comparator | Drug: COLAZAL® Capsules 750 mgCOLAZAL® Capsules 750 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BALSALAZIDE DISODIUM CAPSULES, 750 MG3x750mg, single dose fed | Drug | 1 |
| COLAZAL® Capsules 750 mg3x750mg, single dose fed | Drug | 2 |
Primary outcome
Bioequivalence
Time frame: within 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Mylan Pharmaceuticals Inc. - Clinical Trial ResultsLink provided by the sponsor.
- Daily Med - posting of most recent submitted labelling to the Food and Drug Administration (FDA) and currently in useLink provided by the sponsor.
- Recalls, Market Withdrawals and Safety AlertsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan K Copa, Pharm.D. principal investigator
PRACS Institute, Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BALSALAZIDE DISODIUM CAPSULES, 750 MG and COLAZAL® Capsules 750 mg in people with Healthy, run by Mylan Pharmaceuticals Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bioequivalence (time frame: within 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.