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CompletedNCT00601302Updated Jan 23, 2018

Bioequivalency Study of Amlodipine Tablets Under Fed Conditions

An interventional study of Amlodipine in Hypertension, Chronic Stable Angina and Vasospastic Angina, sponsored by Roxane Laboratories. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-23.

Sponsored by Roxane Laboratories · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

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.

02

Conditions studied

  • Hypertension
  • Chronic Stable Angina
  • Vasospastic Angina
03

In context

Angina Pectoris

519 studies on the registry are indexed under Angina Pectoris; 82 are open to participants now.

This study's enrollment of 40 is below the median of 123 across 336 interventional studies indexed under Angina Pectoris.

Browse Angina Pectoris studies →

Lead sponsor

Roxane Laboratories is the lead sponsor of 98 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion criteria

Exclusion Criteria:

  • Positive test for HIV, Hepatitis B, or Hepatitis C.
  • Treatment with known enzyme altering drugs.
  • History of allergic or adverse response to Amlodipine Besylate or any comparable or similar product.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Interventions

  • DrugAmlodipine
06

What researchers measure

Primary outcomes

  1. Bioequivalence

    Time frame: Baseline, Two period, Twenty-one day washout

07

Study locations

1 site
  • Gateway Medical Research, Inc.
    Saint Charles, Missouri 63301, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00601302
Lead sponsor
Roxane Laboratories
First posted
Jan 28, 2008
Start date
Apr 2004
Primary completion
Apr 2004
Completion
May 2004
Last update
Jan 23, 2018

Study contacts

Walter Parham, MD
principal investigator · Cetero Research, San Antonio

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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