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Sponsored by: |
Ranbaxy Laboratories Limited |
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Information provided by: | Ranbaxy Inc. |
ClinicalTrials.gov Identifier: | NCT00778115 |
The objective of this study is to compare the relative bioavailability of Loperamide HCl 2 mg and simethicone 125 mg tablets (Ranbaxy) with that of Imodium® Advanced caplets (McNeil) in healthy subjects under fasting condition
Condition | Intervention |
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Healthy |
Drug: Loperamide HCl 2 mg and simethicone 125 mg tablets |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Crossover Assignment, Bio-equivalence Study |
Official Title: | A Relative Bioavailability Study of Loperamide HCl 2 mg and Simethicone 125 mg Tablets to Imodium® Advanced Caplets Under Fasting Condition |
Enrollment: | 26 |
Study Start Date: | November 2004 |
Study Completion Date: | December 2004 |
Primary Completion Date: | November 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Loperamide HCl 2 mg and simethicone 125 mg tablets of ranbaxy
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Drug: Loperamide HCl 2 mg and simethicone 125 mg tablets |
2: Active Comparator
Imodium® Advanced caplets
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Drug: Loperamide HCl 2 mg and simethicone 125 mg tablets |
The study was conducted as a single-dose, randomized, 2-period sequence crossover study under fasting condition comparing equal dose of test and reference products with an interval period of at least 7 days. The period of confinement was at least 10 hours before dosing until after 24 hours blood collection in each period. Subjects were asked to return to the clinic for subsequent blood circulation Twenty-six subjects (26) were recruited for the study of which twenty-three (23) completed the clinical portion of the study. Subject #17 was withdrawn by sponsor's representative due to adverse event unrelated to the drug), subject #18 and subject #25 voluntarily withdrew due to adverse event
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Subject candidates who met the following criteria were excluded::
Responsible Party: | Ranbaxy Research Labs ( Dr. Tausif Monif ) |
Study ID Numbers: | B045521 |
Study First Received: | October 22, 2008 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00778115 History of Changes |
Health Authority: | United States: Institutional Review Board |
Bioequivalence Loperamide HCl 2 mg and simethicone 125 mg tablets |
Simethicone Loperamide Healthy Emollients Antidiarrheals |
Simethicone Therapeutic Uses Gastrointestinal Agents Loperamide |
Dermatologic Agents Pharmacologic Actions Emollients Antidiarrheals |