Status:
COMPLETED
Bioavailability Study of Duloxetine Delayed-Release Capsules 60 mg Under Fasting Condition
Lead Sponsor:
Dr. Reddy's Laboratories Limited
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This study were to compare the relative bioavailability of Duloxetine HCl delayed release capsule 60 mg with that of 'CYMBALTA®' delayed release capsule 60 mg (Duloxetine HCl delayed release capsule 6...
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
Eligibility Criteria
Inclusion
- Be healthy human between 18 and 45 years
- Screened within 21 days prior to administration of first dose of study drug
- Having a BMI between 18.5 and 24.9 weight in kg/ height2 in meter
- Be able to communicate effectively with study personnel
- 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).
Exclusion
- History of allergic responses to Duloxetine or other related drugs.
- Have significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG \& X-ray recordings.
- Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system.
- History or presence of bronchial asthma.
- Use of enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication.
- History of drug dependence, recent history of alcoholism or of moderate alcohol use.
- 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 can not refrain from smoking during study period.
- History of difficulty with donating blood or difficulty in accessibility of veins. Donation of blood (I unit: 350 mL/450 mL) within 90 days prior to receiving the first dose of study medication.
- A positive hepatitis screen (includes subtypes A, B, C \& E)
- A positive test result for HIV antibody and/or syphilis (RPR/VDRL).
- The receipt of an investigational product, or participation in a drug research study within a period of 90 days prior to the frst dose of 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT02291367
Start Date
May 1 2008
End Date
May 1 2008
Last Update
November 14 2014
Active Locations (1)
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1
BA Research India Ltd
Ahmedabad, Gujarat, India, 380 054