Bioequivalency Study of Calcitriol Tablets Under Fasting Conditions

• Status: Completed
• Trial end date: 2003-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Roxane Laboratories
• Treatments: Calcitriol

Criteria

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 Calcitriol or any comparable or similar product.