Bioequivalency Study of Amlodipine Tablets Under Fasting Conditions

Completed · Not applicable

Conditions studied: Hypertension, Chronic Stable Angina, Vasospastic Angina

In brief

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.

Key facts

Study ID

NCT00602017

Run by

Roxane Laboratories

People needed

40

Starts

2004-04-01

Expected to finish

2004-05-01

Last updated by the study team

2018-01-23

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Gateway Medical Research, Inc. — Saint Charles, Missouri, United States

Full record on ClinicalTrials.gov

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