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NCT00601302 · ClinicalTrials.gov registry record · NA
Bioequivalency Study of Amlodipine Tablets Under Fed Conditions
A NA study, sponsored by Roxane Laboratories.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT00601302 is a NA study that has completed, run by Roxane Laboratories. The registered enrollment target is 40 participants.
The verdict
NCT00601302, a NA study, has completed, sponsored by Roxane Laboratories.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
The objective of this study was the bioequivalence of a Roxane Laboratories' Amlodipine Besylate tablets, 10 mg, to Norvasc® Tablets, 10 mg (Pfizer) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.
Interventions
- DRUG Amlodipine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2004-04 |
| Est. Completion | 2004-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00601302
The ClinicalTrials.gov registry entry for NCT00601302 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 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 Amlodipine is the first listed.
NCT00601302 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00601302 about?
NCT00601302 is a clinical study titled "Bioequivalency Study of Amlodipine Tablets Under Fed Conditions". The objective of this study was the bioequivalence of a Roxane Laboratories' Amlodipine Besylate tablets, 10 mg, to Norvasc® Tablets, 10 mg (Pfizer) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.
What is the current status of trial NCT00601302?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2004-04. Estimated completion is 2004-05.
What interventions are being tested in trial NCT00601302?
The interventions under investigation include: Amlodipine (DRUG).
Who is sponsoring clinical trial NCT00601302?
This trial is sponsored by Roxane Laboratories, which has 93 total clinical trials registered on ClinicalTrials.gov.
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