Bioequivalence Study on Pseudoephedrine HCl 120 mg ER Tablets Under Fasting Conditions

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00779831
• Date of registration: 23/10/2008
• Primary sponsor: Ranbaxy Laboratories Limited
• Public title: Bioequivalence Study on Pseudoephedrine HCl 120 mg ER Tablets Under Fasting Conditions
• Scientific title: Comparative, Randomized, Single Dose, 2 Way Crossover Bioavailability Study of Ranbaxy and Warner - Lambert (Sudafed ® 12 Hour) 120 mg Pseudoephedrine Hydrochloride Extended - Release Tablets in Healthy Adult Volunteers Under Fasting Conditions.
• Date of first enrolment: June 2004
• Target sample size: 36
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00779831
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Countries of recruitment

Canada

Key inclusion & exclusion criteria

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

Exclusion Criteria:

- Subjects were excluded from the study if there was evidence of any of the following
at screening or at any time during the study:

1. History or presence of significant cardiovascular, pulmonary, hepatic, renal,
hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic,
or psychiatric disease

2. In addition, history or presence of:

1. Alcoholism or drug abuse within the past year

2. Hypersensitivity or idiosyncratic reaction to Pseudoephedrine or any other
sympathomimetic amines

3. Glaucoma or hypermetropia

3. Female subjects who are pregnant or lactating

4. Positive results on HIV, HbsAg and HCV tests

5. Subjects receiving a monoamine oxidase (MAO) inhibitor or within 14 days of
stopping use of an MAO inhibitor, or any sympathomimetic amines

6. Subjects who have been on a special diet (for whatever reason) during the 28
days prior to the first dose and throughout the study

7. Subjects who through completion of the study, would have donated in excess of:

- 500 mL of blood in 14 days

- 1500 mL of blood in 180 days

- 2500 mL of blood in 1 year. 8. Subjects who have participated in another clinical
trial within 28 days prior to the first dose.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: 120 mg Pseudoephedrine hydrochloride extended release tablets

Primary Outcome(s)

Bioequivalence [Time Frame: No]

Secondary ID(s)

AA16795

Source(s) of Monetary Support

Please refer to primary and secondary sponsors