Healthy
Conditions
Keywords
Bioequivalence Pseudoephedrine hydrochloride 120 mg extended release tablets
Brief summary
Compare bioavailability of Pseudoephedrine hydrochloride extended release tablets (Ranbaxy Laboratories Limited) against reference product Sudafed ® 12-hour tablets 120 mg (Warner-Lambert) under fasting conditions.
Detailed description
This was an open label, randomized, single dose, 2-way crossover, relative bioavailability study performed on a total of 36 healthy adult subjects (20 males and 16 females). Thirty five (35) subjects (19 males and 16 females) completed the clinical phase of the study. In each period, subjects were housed from at least 10 hours before dosing until after the 36 hour blood draw. Single oral 120 mg Pseudoephedrine hydrochloride doses were separated by a washout period of 7 days. A total of thirty six (36) subjects (20 males and 16 females) were enrolled in the study. Out of which a total of thirty five (35) subjects (19 males and 16 females) completed the clinical phase of the study.
Interventions
DRUG120 mg Pseudoephedrine hydrochloride extended release tablets
Sponsors
Ranbaxy Laboratories Limited
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* All subjects enrolled in this study met all inclusion and
Exclusion criteria
, and were judged by the investigator to be normal, healthy volunteers Subjects were included in the study if they met all of the following criteria: 1. Healthy adult male or female volunteers , 18 to 55 years of age 2. Weighing at least 52 kg for males and 45 kg for females and within 15% of their ideal weights (table of 'Desirable Weights of Adults', Metropolitan Life Insurance Company, 1983) 3. Medically healthy subjects with clinically normal laboratory profiles and ECGs 4. Females of child bearing potential should either be sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or be using one of the following acceptable birth control methods: 1. Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum 2. IUD in place for at least 3 months 3. Barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the first dose and throughout the study 4. Surgical sterilization of the partner (vasectomy for 6 months minimum) 5. Hormonal contraceptives for at least 3 months prior to the first dose of the study 6. Other birth control methods may be deemed acceptable 5. Post menopausal women with amenorrhea for at least 2 years will be eligible 6. Voluntarily consent to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bioequivalence | — |
Countries
Canada
Outcome results
None listed