Bioequivalency Study of Calcitriol Tablets Under Fasting Conditions

Roxane Laboratories

Status

Completed

Conditions

Hypocalcemia

Secondary Hyperparathyroidism

Treatments

Drug: Calcitriol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00601328

CALC-07

Details and patient eligibility

About

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

Enrollment

36 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.