Bioequivalence Study of Zafirlukast Tablets 20 mg of Dr. Reddy's Laboratories Limited Under Fasting Condition

An Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Bioavailability Study Of Zafirlukast Tablets 20 mg of Dr. Reddy's Laboratories Limited, India Comparing With That of 'ACCOLATE' Tablets 20 mg of Astrazeneca Pharmaceuticals, USA In Healthy Adult Human Subjects Under Fasting Conditions.

The objective of this study was to compare the relative bioavailability of zafirlukast tablets 20 mg with that of 'ACCOLATE®' tablets 20 mg (zafirlukast tablets 20 mg) in healthy, adult, human, subjects under fasting conditions and to monitor safety of subjects.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Zafirlukast

Detailed Description

open label, randomized, two-period, two treatment, two sequence, crossover, balanced single dose comparative oral bioavailability study in healthy, adult, human subjects under fasting conditions.44 healthy, adult, human subjects.There was 11-day interval between treatments.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Bodakdev
    • Ahmedabad, Bodakdev, India, 380 054
      • BA Research India Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The subjects should be healthy human between 18 and 45 years.
2. The subjects should be screened within 21 days prior to the administration of first dose of the study drug.
3. The subjects should have a BMI between 18.5 and 24.9 weight in kg/ height2 in meter.
4. The subjects should be able to communicate effectively with study personnel.

5. The subjects should be able to give written informed consent to participate in the study.

   If subject is a female volunteer and

6. Is of child bearing potential 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.
7. Is postmenopausal for at least 1 year.
8. Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).

Exclusion Criteria:

1. The subjects who have a history of allergic responses to zafirlukast or other related drugs.
2. The subjects who have used enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication.
3. The subjects who have history of drug dependence, recent history of alcoholism or of moderate alcohol uses.
4. The subjects who have significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG and X-ray recordings.
5. The subjects who have any disease or condition which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system.
6. The subjects who have a history or presence of bronchial asthma
7. The subjects who are smokers who smoke more than or equal to 10 cigarettes per day or more than or equal to 20 biddies per day or those who cannot refrain from smoking during study period.
8. The subjects with a history of difficulty with donating blood or difficulty in accessibility of veins.
9. The subjects who have donated 1 unit (350 ml / 450 ml) blood within 90 days prior to receiving the first dose of study medication.
10. The subjects who have a positive hepatitis screen (includes subtypes A, B, C and E)
11. The subjects who have a positive test result for HIV antibody and / or syphilis(RPR/VDRL).
12. The subject who receives an investigational product, or has participated in a drug research study within a period of 90 days prior to the first dose of the study medication administration.
13. Female volunteers demonstrating a positive pregnancy screen.
14. Female volunteers who are currently breast-feeding.
15. Female volunteers not willing to use contraception during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: zafirlukast; Zafirlukast Tablets 20 mg of Dr. Reddys Laboratories Limited	Drug: Zafirlukast; Zafirlukast tablets 20 mg; Other Names: Accolate tablets 20 mg
Active Comparator: Accolate; ACCOLATE tablets manufactured by IPR pharmaceuticals and manufactured for Astrazeneca Pharmaceuticals	Drug: Zafirlukast; Zafirlukast tablets 20 mg; Other Names: Accolate tablets 20 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bioequivalence on Cmax and AUC parameters	13 days

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited
• Investigators: Principal Investigator: Ronak Modi, MBBS, BA Research India Ltd.

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: January 24, 2011
• First Submitted That Met QC Criteria: January 24, 2011
• First Posted (Estimate): January 25, 2011

Study Record Updates

• Last Update Posted (Estimate): January 26, 2011
• Last Update Submitted That Met QC Criteria: January 25, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Zafirlukast
• Other Study ID Numbers: BA0759156