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

Information source: Ranbaxy Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Pseudoephedrine hydrochloride 120 mg ER tablets (Drug)

Phase: N/A

Status: Completed

Sponsored by: Ranbaxy Laboratories Limited

Summary

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.

Clinical Details

Official title: 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.

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Primary outcome: Bioequivalence

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.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

Criteria:

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.

Locations and Contacts

Ranbaxy CPU, Gurgaon, Haryana, India
Additional Information

Starting date: June 2004
Last updated: October 23, 2008

Page last updated: August 20, 2015

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