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

Ranbaxy

Status

Completed

Conditions

Healthy

Treatments

Drug: Pseudoephedrine hydrochloride 120 mg ER tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT00779805

016/ PSEUD-120/ 04

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.