Bioequivalency Study of Calcitriol Tablets Under Fasting Conditions
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Endocrine |
| Therapuetic Areas: | Endocrinology, Other |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 1/25/2018 |
| Start Date: | July 2003 |
| End Date: | August 2003 |
A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalency Study of Calcitriol Tablets, 0.25 mg, Under Fasting Conditions
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
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
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.
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