Bioequivalency Study of Amlodipine Tablets Under Fasting Conditions

• Sponsor: Roxane Laboratories (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00602017
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Duration (Days): 30
• Patients Per Site Per Month: 40.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension; Chronic Stable Angina; Vasospastic Angina	Drug: Amlodipine	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Single Dose, Two-Period, Two-Treatment, 2-Way Crossover Bioequivalency Study of 10 mg Amlodipine Besylate Tablets Under Fasting Conditions
• Study Start Date: Apr 1, 2004
• Actual Primary Completion Date: May 1, 2004
• Actual Study Completion Date: May 1, 2004

Outcome Measures

Primary Outcome Measures

1. Bioequivalence [Baseline, Two period, Twenty-one day washout]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: 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:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gateway Medical Research, Inc.	Saint Charles	Missouri	United States	63301

Sponsors and Collaborators

• Roxane Laboratories

Investigators

• Principal Investigator: Steven Herrmann, MD, Cetero Research, San Antonio

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00602017
• Other Study ID Numbers: AMLO-01
• First Posted: Jan 28, 2008
• Last Update Posted: Jan 23, 2018
• Last Verified: Jan 1, 2018

• Additional relevant MeSH terms: Angina Pectoris; Angina, Stable; Angina Pectoris, Variant; Amlodipine

Study Results

No Results Posted as of Jan 23, 2018