Bioequivalence Study of Pseudoephedrine HCl 120 mg ER Tablets Under Fed Conditions

October 23, 2008 updated by: Ranbaxy Laboratories Limited

An Open Label, Balanced, Randomised, Two-Treatment, Two-Period, Two-Sequence, Single-Dose, Crossover Bioavailability Study on Pseudoephedrine Hydrochloride Formulations Comparing Pseudoephedrine Hydrochloride 120 mg ER Tablets of Ranbaxy Laboratories With Sudafed 120 mg ER Tablets of Pfizer Consumer Health Care in Healthy, Adult, Human Subjects Under Fed Conditions.

The objective of the study was to compare the single dose oral bioavailability of Pseudoephedrine hydrochloride 120 mg ER tablets of Ranbaxy with Sudafed 120 mg ER tablets of Pfizer Consumer Health Care in healthy, adult, human subjects under fed conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study was an open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover bioavailability study planned on 40 healthy, adult, human subjects under fed conditions.

A total of forty (40) healthy, adult, human subjects were admitted in the study to allow the dosing in the first period. Out of the forty subjects, only thirty eight (38) subjects completed both the periods of the study.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Haryana
      • Gurgaon, Haryana, India
        • Ranbaxy CPU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Be in the age range of 18 - 45 years
  • Be neither over weight nor under weight for his/ her height as per the Life Insurance Corporation of India height/ weight chart for non-medical cases
  • Have voluntarily given written informed consent to participate in this study
  • Be of normal health as determined by medical history and physical examination of the subjects performed within 14 days prior to the commencement of the study
  • If female and:
  • Of child bearing potential is practicing an acceptable method of birth control for the duration of the study as judged by the investigator (s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence; or
  • Is postmenopausal for at least 1 year; or
  • Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)

Exclusion Criteria:

  • History of allergy to Pseudoephedrine or other sympathomimetic drugs
  • History of intake of any sympathomimetic drugs and glucocorticoids during a period of 15 days prior to day 1 of this study.
  • Concurrent use of monoamine oxidase inhibitor (MAOI) drugs within 14 days prior to day 1 of this study
  • Any evidence of organ dysfunction or any clinically significant deviations from the normal, in physical or clinical determinations
  • Presence of disease markers of HIV 1 or 2, hepatitis B or C viruses or syphilis infection
  • Female volunteers demonstrating a positive pregnancy test
  • Female volunteers who are currently breastfeeding
  • Presence of values which are significantly different from normal reference ranges (as defined in appendix 5) and/ or judged clinically significant for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum cholesterol
  • Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (>4/ HPF), glucose (positive) or protein (positive)
  • Clinically abnormal ECH or chest X-ray
  • History of serious gastrointestinal, hepatic, renal, pulmonary, neurological or hematological diseases or glaucoma
  • History of cardiovascular disorders (including hypertension), endocrine disorders, hyperthyroidism, diabetes mellitus, prostatic hypertrophy, palpitations, insomnia, tremors or bronchial asthma
  • History of any psychiatric illness which may impair the ability to provide written informed consent
  • Regular smokers who smoke more than 10 cigarettes daily or have difficulty abstaining from smoking for the duration of each study period.
  • History of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or have difficulty in abstaining for the duration of each study period
  • Use of any enzyme modifying drugs within 30 days prior to day 1 of this study
  • Participation in any clinical trail within 12 weeks preceding day 1 of this study
  • Subjects who, through completion of this study, would have donated and / or lost more than 350 mL of blood in the past 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Pseudoephedrine hydrochloride 120 mg ER tablets of Ranbaxy
Drug: Pseudoephedrine hydrochloride 120 mg ER tablets
Active Comparator: 2
Sudafed 120 mg ER tablets
Drug: Pseudoephedrine hydrochloride 120 mg ER tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Bioequivalence

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ranbaxy Laboratories Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

June 1, 2004

Study Completion (Actual)

October 1, 2004

Study Registration Dates

First Submitted

October 23, 2008

First Submitted That Met QC Criteria

October 23, 2008

First Posted (Estimate)

October 24, 2008

Study Record Updates

Last Update Posted (Estimate)

October 24, 2008

Last Update Submitted That Met QC Criteria

October 23, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 016/ PSEUD-120/ 04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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