Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Interventions

  • DRUG Amlodipine

Study Locations (1)

Missouri

  • Gateway Medical Research, Inc. - Saint Charles

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2004-04
Est. Completion 2004-05
Phase NA
Roxane Laboratories

93 total trials

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.

Similar trials for Hypertension

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

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.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT01306019 · 40 participants · Phase 1

    Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID)

  • NCT01608152 · 40 participants

    Development of a Video Game for the Improvement of Outcomes in Stem Cell Transplant Survivors

  • NCT01668082 · 40 participants · NA

    An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection

  • NCT02015013 · 40 participants · Phase 2

    Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT00602017, the US trial registry maintained by the National Library of Medicine. NCT00602017 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.