Overview

Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Montelukast Sodium Chewable 5mg Tablet Under Fed Conditions

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Male
Summary
Objective: Primary objective of the present study was to compare the single dose bioavailability of Torrent's Montelukast Sodium chewable 5mg tablet and Innovator's(Merck)Singulair chewable 5mg tablet. Dosing periods were separated by a washout period during fed study. Study Design: Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Torrent Pharmaceuticals Limited
Treatments:
Montelukast
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.