NCT02322632

Bioequivalence Study of Paricalcitol Capsules, 4 mcg Under Fasting Conditions

An Open-label, Balanced, Randomized, Two-treatment, Two-sequence, Two-period, Single-dose, Crossover Oral Bioequivalence Study of Paricalcitol Capsules 4 mcg of Dr. Reddy's Laboratories Limited and Zemplar Capsules, 4 mcg of Abbott Laboratories, USA in Healthy, Adult, Human Subjects Under Fasting Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

An open-label, balanced, randomized, two-treatment, two-sequence, two-period, single-dose, crossover oral bioequivalence study in healthy subjects under fasting conditions.

Detailed description

An open-label, balanced, randomized, two-treatment, two-sequence, two-period, single-dose, crossover oral bioequivalence study of Paricalcitol Capsules 4 mcg of Dr. Reddy's Laboratories Limited and Zemplar® Capsules 4 mcg of Abbott Laboratories, USA in healthy, adult, human subjects under fasting conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Paricalcitol Capsules, 4 mcg	Paricalcitol Capsules, 4 mcg of Dr. Reddy's Laboratories Limited

Timeline

• Start date: 2010-11-01
• Primary completion: 2010-12-01
• Completion: 2011-02-01
• First posted: 2014-12-23
• Last updated: 2014-12-23

Locations

1 site across 1 country: India