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

NCT01283061 | Completed Phase 1

• 1 other identifier: BA0759156
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Bioequivalence on Cmax and AUC parameters

  13 days

Study Arms (2)

zafirlukast

EXPERIMENTAL

Zafirlukast Tablets 20 mg of Dr. Reddys Laboratories Limited

Drug: Zafirlukast

Accolate

ACTIVE COMPARATOR

ACCOLATE tablets manufactured by IPR pharmaceuticals and manufactured for Astrazeneca Pharmaceuticals

Drug: Zafirlukast

Interventions

Zafirlukast DRUG

Zafirlukast tablets 20 mg

Also known as: Accolate tablets 20 mg

Accolate; zafirlukast

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subjects should be healthy human between 18 and 45 years.
• The subjects should be screened within 21 days prior to the administration of first dose of the study drug.
• The subjects should have a BMI between 18.5 and 24.9 weight in kg/ height2 in meter.
• The subjects should be able to communicate effectively with study personnel.
• The subjects should be able to give written informed consent to participate in the study.
• If subject is a female volunteer and
• 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.
• Is postmenopausal for at least 1 year.
• Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).

You may not qualify if:

• The subjects who have a history of allergic responses to zafirlukast or other related drugs.
• The subjects who have used enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication.
• The subjects who have history of drug dependence, recent history of alcoholism or of moderate alcohol uses.
• The subjects who have significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG and X-ray recordings.
• 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.
• The subjects who have a history or presence of bronchial asthma
• 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.
• The subjects with a history of difficulty with donating blood or difficulty in accessibility of veins.
• The subjects who have donated 1 unit (350 ml / 450 ml) blood within 90 days prior to receiving the first dose of study medication.
• The subjects who have a positive hepatitis screen (includes subtypes A, B, C and E)
• The subjects who have a positive test result for HIV antibody and / or syphilis(RPR/VDRL).
• 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.
• Female volunteers demonstrating a positive pregnancy screen.
• Female volunteers who are currently breast-feeding.
• Female volunteers not willing to use contraception during the study.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

BA Research India Ltd.

Ahmedabad, Bodakdev, 380 054, India

Location

MeSH Terms

Interventions

zafirlukast

Study Officials

• Ronak Modi, MBBS

  BA Research India Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 24, 2011
• First Posted: January 25, 2011
• Study Start: December 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: January 26, 2011

Record last verified: 2011-01

Locations

IN (1)