Bioequivalence Study of Torrent Pharmaceuticals Ltd's Alfuzosin ER Tablets Under Fed Conditions

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01418599
• Date of registration: 15/08/2011
• Primary sponsor: Torrent Pharmaceuticals Limited
• Public title: Bioequivalence Study of Torrent Pharmaceuticals Ltd's Alfuzosin ER Tablets Under Fed Conditions
• Scientific title: An Open Label, Randomised, Two Period, Two Treatment, Two Sequence, Crossover, Single-Dose Bioequivalence Study of Torrent Pharmaceuticals Ltd's Alfuzosin ER Tablets vs. Sanofi's Uroxatral ER Tablets in Healthy Human Subjects Under Fed Conditions
• Date of first enrolment: August 2011
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01418599
• Study type: Interventional
• Study design: N/A

Countries of recruitment

India

Key inclusion & exclusion criteria

Inclusion Criteria:

- The volunteers were included in the study based on the following criteria:

- Sex: male.

- Age: 18 - 45 years. .

- Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.

- Healthy and willing to participate in the study.

- Volunteer willing to adhere to the protocol requirements and to provide written
informed consent.

- Non-smokers or smoker who smokes less than 10 cigarettes per day

Exclusion Criteria:

- The volunteers were excluded from the study based on the following criteria:

- Clinically relevant abnormalities in the results of the laboratory screening
evaluation.

- Clinically significant abnormal ECG or Chest X-ray.

- Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic
blood pressure less than 60 mm Hg or more than 90 mm Hg.

- Pulse rate less than 50/minute or more than 100/minute.

- Oral temperature less than 95°P or more than 98.6°P.

- Respiratory rate less than 12/minute or more than 20/minute

- History of allergy to the test drug or any drug chemically similar to the drug
under investigation.

- History of alcohol or drug abuse

- Positive breath alcohol test

- Recent history of kidney or liver dysfunction.

- History of consumption of prescribed medication since last 14 days or OTC
medication since last 07 days before beginning of the study.

- Volunteers suffering from any chronic illness such as arthritis, asthma etc.

- History of heart failure.

- HIV, HCV, HBsAg positive volunteers.

- Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, - - -
Cocaine positive volunteers based on urine test.

- Volunteers suffering from any psychiatric (acute or chronic) illness requiring
medications.

- Administration of any study drug in the period 0 to 3 months before entry to the
study.

- History of significant blood loss due to any reason, including blood donation in
the past 3 months.

- History of pre-existing bleeding disorder.

- Existence of any surgical or medical condition, which, in the judgment of the
chief investigator and/or clinical investigator/physician, might interfere with
the absorption, distribution, metabolism or excretion of the drug or likely to
compromise the safety of volunteers.

- Inability to communicate or co-operate due to language problem, poor mental
development or impaired cerebral function.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Torrent's Alfuzosin Extended Release Tablet

Primary Outcome(s)

bioequivalence based on Composite of Pharmacokinetics [Time Frame: bioequivalence; 90% geometric confidence interval of the ratio of least-squares means of the test to reference product should be within 80.00% - 125.00% for AUC-unf, AUCo-t and Cmax.]

Secondary ID(s)

PK-06-107

Source(s) of Monetary Support

Please refer to primary and secondary sponsors