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

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01283061
First received: January 24, 2011
Last updated: January 25, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Zafirlukast
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bioequivalence on Cmax and AUC parameters [ Time Frame: 13 days ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: December 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: zafirlukast
Zafirlukast Tablets 20 mg of Dr. Reddys Laboratories Limited
Drug: Zafirlukast
Zafirlukast tablets 20 mg
Other Name: 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 Name: Accolate tablets 20 mg

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01283061

Locations
India
BA Research India Ltd.
Ahmedabad, Bodakdev, India, 380 054
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Ronak Modi, MBBS BA Research India Ltd.
  More Information

No publications provided

Responsible Party: Director-Research & Development, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01283061     History of Changes
Other Study ID Numbers: BA0759156
Study First Received: January 24, 2011
Last Updated: January 25, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Zafirlukast
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 31, 2014