Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT00775918
Status:
COMPLETED
Last Update Posted:
2008-10-20
First Post:
2008-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivaelnce Study of Doxycycline Monohydrate 100mg Tablets Under Fed Conditions
Sponsor:
Ranbaxy Laboratories Limited
Organization:
Study Overview
Official Title:
Single Dose Two-Way Crossover Fed Bioequivalence Study of Doxycycline Monohydrate 100 mg Tablets in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2008-10
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:
The purpose of this study was to determine the bioequivalence of Doxycycline monohydrate formulations after administration of single doses to normal healthy subjects under fed conditions. These data were to be evaluated statistically to determine if the products meet bioequivalence criteria.
Detailed Description:
The study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover , bioequivalence study on Doxycycline monohydrate comparing Doxycycline monohydrate 100mg tablets of Ranbaxy Pharmaceuticals Inc with Adoxa ® 100 mg tablets of Bradley Pharmaceuticals Inc. in healthy, adult, human, subjects under fed conditions.
A total of 32 non-smoking subjects (21 men and 11 women) were included in this study, of which 32 finished the study according to the protocol.
A total of 32 non-smoking subjects (21 men and 11 women) were included in this study, of which 32 finished the study according to the protocol.
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?: