Ignite Creation Date:
2025-12-24 @ 9:50 PM
Ignite Modification Date:
2026-03-01 @ 5:38 PM
Study NCT ID:
NCT02322632
Status:
COMPLETED
Last Update Posted:
2014-12-23
First Post:
2014-12-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioequivalence Study of Paricalcitol Capsules, 4 mcg Under Fasting Conditions
Sponsor:
Dr. Reddy's Laboratories Limited
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: