Status:
COMPLETED
Bioequivalence Study of Pseudoephedrine HCl 120 mg ER Tablets Under Fed Conditions
Lead Sponsor:
Ranbaxy Laboratories Limited
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
NA
Brief 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 Ca...
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 conditio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2004
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00779805
Start Date
June 1 2004
End Date
October 1 2004
Last Update
October 24 2008
Active Locations (1)
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1
Ranbaxy CPU
Gurgaon, Haryana, India