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NCT00618228 · ClinicalTrials.gov registry record · NA
Bioequivalency Study of Balsalazide Capsules Under Fasting Conditions
A NA study, sponsored by Roxane Laboratories.
- Completed
- Registry status
- NA
- Development phase
- 52
- Enrollment target
NCT00618228 is a NA study that has completed, run by Roxane Laboratories. The registered enrollment target is 52 participants.
The verdict
NCT00618228, a NA study, has completed, sponsored by Roxane Laboratories.
- COMPLETED
- Registry status
- NA
- Development phase
- 52 participants
- Enrollment target
Study Summary
The objective of this study was to assess bioequivalence of a potential generic 750 mg balsalazide disodium capsule formulation compared with Salix Pharmaceutical's 750 mg balsalazide disodium capsule, Colazal, following a single 750 mg dose, under fasting conditions.
Interventions
- DRUG Balsalazide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2004-01 |
| Est. Completion | 2004-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00618228
The ClinicalTrials.gov registry entry for NCT00618228 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Roxane Laboratories, which has 93 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Balsalazide is the first listed.
NCT00618228 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00618228 about?
NCT00618228 is a clinical study titled "Bioequivalency Study of Balsalazide Capsules Under Fasting Conditions". The objective of this study was to assess bioequivalence of a potential generic 750 mg balsalazide disodium capsule formulation compared with Salix Pharmaceutical's 750 mg balsalazide disodium capsule, Colazal, following a single 750 mg dose, under fasting conditions.
What is the current status of trial NCT00618228?
This trial is currently completed. It is a NA study. The enrollment target is 52 participants. The study started on 2004-01. Estimated completion is 2004-01.
What interventions are being tested in trial NCT00618228?
The interventions under investigation include: Balsalazide (DRUG).
Who is sponsoring clinical trial NCT00618228?
This trial is sponsored by Roxane Laboratories, which has 93 total clinical trials registered on ClinicalTrials.gov.
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