Ignite Creation Date:
2024-05-05 @ 10:17 PM
Last Modification Date:
2024-10-26 @ 10:17 AM
Study NCT ID:
NCT01079065
Status:
COMPLETED
Last Update Posted:
2010-03-02
First Post:
2010-02-18
Brief Title:
A Relative Bioavailability Study of 20 mg Famotidine Tablets Under Fasting Condition
Sponsor:
Ranbaxy Laboratories Limited
Organization:
Ranbaxy Inc
Study Overview
Official Title:
An Open Label Balanced Randomized Two-treatment Two-period Two-sequence Single-dose Crossover Bioavailability Study Comparing Famotidine 20 mg Tablets of OHM Laboratories a Subsidiary of Ranbaxy Pharmaceutical Inc With PEPCID AC Tablets Containing Famotidine 20 mg of Johnson Johnson Merck Consumer Pharmaceutical Co in Healthy Adult Human Male Subjects Under Fasting Condition
Status:
COMPLETED
Status Verified Date:
2010-03
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 study was conducted as an open-label balanced randomized two-treatment two-period two-sequence single-dose crossover bioavailability study comparing famotidine tablets USP 20 mg manufactured by OHM Laboratories with Pepcid AC Acid reducer famotidine tablets 20 mg containing famotidine 20 mg distributed by Johnson Johnson Merck Consumer Pharmaceutical Co Fort Washington PA 19034 USA under fasting conditions
Detailed Description:
Following an overnight fast of at least 10 hour a single oral dose of famotidine tablets USP 20 mg or Pepcid AC Acid reducer famotidine tablets 20 mg containing famotidine 20 mg was administered during each period of the study along with 240 mL of drinking water at ambient temperature and under supervision of trained study personnel
During the course of the study safety parameters assessed were vital signs clinical examination medical history and clinical laboratory safety tests hematology biochemical parameters serology and urine analysis at baseline Adverse event monitoring was done throughout the study Laboratory parameters of hematology and biochemistry except blood glucose and cholesterol were repeated at the end of the study for all the subjects
During the course of the study safety parameters assessed were vital signs clinical examination medical history and clinical laboratory safety tests hematology biochemical parameters serology and urine analysis at baseline Adverse event monitoring was done throughout the study Laboratory parameters of hematology and biochemistry except blood glucose and cholesterol were repeated at the end of the study for all the subjects
Study Oversight
Has Oversight DMC:
None
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?:
None