Bioequivalence Study of Loperamide Hydrochloride 2 mg and Simethicone 125 mg Tablet Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Ranbaxy Inc.
ClinicalTrials.gov Identifier:
NCT00778115
First received: October 22, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

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
Healthy
Drug: Loperamide HCl 2 mg and simethicone 125 mg tablets

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Relative Bioavailability Study of Loperamide HCl 2 mg and Simethicone 125 mg Tablets to Imodium® Advanced Caplets Under Fasting Condition

Resource links provided by NLM:


Further study details as provided by Ranbaxy Inc.:

Primary Outcome Measures:
  • Bioequivalence [ Designated as safety issue: No ]

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
Experimental: 1
Loperamide HCl 2 mg and simethicone 125 mg tablets of ranbaxy
Drug: Loperamide HCl 2 mg and simethicone 125 mg tablets
Active Comparator: 2
Imodium® Advanced caplets
Drug: Loperamide HCl 2 mg and simethicone 125 mg tablets

Detailed Description:

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 Subject #17 was withdrawn by sponsor's representative due to adverse event unrelated to the drug), subject #18 and subject #25 voluntarily withdrew due to adverse event

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. All subjects selected for this sudy will be at least 18 years of age
  2. Each subjects shall be given a general physical examination within 28 days of initiation of the study. Such examination includes, but is not limited to, blood pressure, general observations, and history
  3. Each female subject will be given a serum pregnancy test as part of the pre-study screening process At the end of the study, the subjects will have an exit evaluation, and clinical laboratory measurements Adequate blood and urine samples should be obtained within 28 days before beginning of the first period and at the end of the clinical laboratory measurements Clinical laboratory measurement will include the haematology, clinical chemistry, urine analysis, HIV screen, Hepatitis-B,C screen, Drugs of abuse screen

Exclusion Criteria:

Subject candidates who met the following criteria were excluded::

  1. Subjects with a history of alcoholism or drug addiction (during past 2 years), or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible for study
  2. Subjects whose clinical laboratory tests are outside the normal range may be retested at the request of clinical investigator. If the clinical values are outside this range on retesting, subject will not be eligible to participate in the study unless the clinical investigator deems the result to not to be significant
  3. Subjects who have a history of allergic responses to the class of drug being tested should be excluded from the study
  4. All subjects will have urine samples assayed for the presence of drugs of abuse as a part of the clinical laboratory screening procedure and at each check-in. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate
  5. Subjects should not have donated blood and/ or plasma for at least 30 days prior to the first dosing of the study
  6. Subjects who have taken investigational drug within 30 days prior to the first dosing of the study
  7. Female subjects who are pregnant, breast feeding, or who are likely to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (eg. Condom, IUD) of contraception during course of the study or they will not be allowed to participate. Subjects who have used implanted or injected hormonal contraceptives before 14 days of dosing will not be allowed to participate
  8. All female subjects will be screened for pregnancy at check-in in each period. Subjects with positive or inconclusive results will be withdrawn from the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00778115

Locations
United States, Missouri
Gateway Medical Research, Inc.
St. Charles, Missouri, United States, 63301
Sponsors and Collaborators
Ranbaxy Laboratories Limited
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Tausif Monif, Ranbaxy Research Labs
ClinicalTrials.gov Identifier: NCT00778115     History of Changes
Other Study ID Numbers: B045521
Study First Received: October 22, 2008
Last Updated: October 22, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Ranbaxy Inc.:
Bioequivalence Loperamide HCl 2 mg and simethicone 125 mg tablets

Additional relevant MeSH terms:
Loperamide
Antidiarrheals
Simethicone
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antifoaming Agents
Molecular Mechanisms of Pharmacological Action
Emollients
Dermatologic Agents

ClinicalTrials.gov processed this record on August 28, 2014