Bioequivalency Study of Calcitriol Tablets Under Fasting Conditions

Completed · Not applicable

Conditions studied: Secondary Hyperparathyroidism, Hypocalcemia

In brief

The objective of this study was to assess the bioequivalence of Roxane Laboratories' Calcitriol capsules, 0.25 mcg, to ROCALTROL® capsules, 0.25 mcg (Roche) using a single-dose, 2-treatment, 2-period, crossover design, under fasting conditions

Key facts

Study ID

NCT00601328

Run by

Roxane Laboratories

People needed

36

Starts

2003-07-01

Expected to finish

2003-08-01

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 Calcitriol or any comparable or similar product.

Where it is running

• Bio-Kinetic Clinical Applications, Inc. — Springfield, Missouri, United States

Full record on ClinicalTrials.gov

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