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NCT00602017 · ClinicalTrials.gov registry record · NA
Bioequivalency Study of Amlodipine Tablets Under Fasting Conditions
A NA study of Hypertension and Chronic Stable Angina, sponsored by Roxane Laboratories.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT00602017: Completed NA study of Hypertension and Chronic Stable Angina, sponsored by Roxane Laboratories.
NCT00602017 is a NA study of Hypertension and Chronic Stable Angina that has completed, run by Roxane Laboratories. The registered enrollment target is 40 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00602017, a NA study of Hypertension and Chronic Stable Angina, has completed, sponsored by Roxane Laboratories.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
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 fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.
Conditions Studied
Interventions
- DRUG Amlodipine
Study Locations (1)
Missouri
- Gateway Medical Research, Inc. - Saint Charles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2004-04 |
| Est. Completion | 2004-05 |
| Phase | NA |
What the finished NCT00602017 record still lists
NCT00602017 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with Hypertension appearing as the primary indexed condition, and to 1 intervention - of which Amlodipine is the first listed.
NCT00602017 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT00602017 about?
NCT00602017 is a clinical study titled "Bioequivalency Study of Amlodipine Tablets Under Fasting 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 fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.
What is the current status of trial NCT00602017?
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 conditions does trial NCT00602017 study?
This clinical trial studies the following conditions: Hypertension, Chronic Stable Angina, Vasospastic Angina.
What interventions are being tested in trial NCT00602017?
The interventions under investigation include: Amlodipine (DRUG).
Who is sponsoring clinical trial NCT00602017?
This trial is sponsored by Roxane Laboratories, which has 93 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00602017 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00602017's enrollment target sits among peer trials
40 384th of 470 higher than 80 of 470 other Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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