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NCT00846196 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Bioequivalence of Different Formulations of Risedronate in Healthy Male and Female Subjects
A Phase 1 study, sponsored by Warner Chilcott.
- Completed
- Registry status
- Phase 1
- Development phase
- 538
- Enrollment target
NCT00846196 is a Phase 1 study that has completed, run by Warner Chilcott. The registered enrollment target is 538 participants.
The verdict
NCT00846196, a Phase 1 study, has completed, sponsored by Warner Chilcott.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 538 participants
- Enrollment target
Study Summary
Randomized, double-blind, 2-treatment, 2-period, 2-sequence, crossover study, The study will consist of a screening visit, study center admission (preceding Treatment Periods 1 and 2), 2 treatment periods (4 days each), 1 washout period (14 to 17 days separating periods 1 and 2), and exit procedures.
Interventions
- DRUG risedronate DR (Phase III clinical supply)
- DRUG risedronate 35 mg DR (Commercial Tablet)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 538 participants |
| Start Date | 2009-01 |
| Est. Completion | 2009-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00846196
The ClinicalTrials.gov registry entry for NCT00846196 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 538 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Warner Chilcott, which has 53 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which risedronate DR (Phase III clinical supply) is the first listed.
NCT00846196 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00846196 about?
NCT00846196 is a clinical study titled "A Study to Assess the Bioequivalence of Different Formulations of Risedronate in Healthy Male and Female Subjects". Randomized, double-blind, 2-treatment, 2-period, 2-sequence, crossover study, The study will consist of a screening visit, study center admission (preceding Treatment Periods 1 and 2), 2 treatment periods (4 days each), 1 washout period (14 to 17 days separating periods 1 and 2), and exit procedures...
What is the current status of trial NCT00846196?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 538 participants. The study started on 2009-01. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00846196?
The interventions under investigation include: risedronate DR (Phase III clinical supply) (DRUG), risedronate 35 mg DR (Commercial Tablet) (DRUG).
Who is sponsoring clinical trial NCT00846196?
This trial is sponsored by Warner Chilcott, which has 53 total clinical trials registered on ClinicalTrials.gov.
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