Bioavailability Study of Duloxetine Delayed-Release Capsules 60 mg Under Fasting Condition
NCT ID: NCT02291367
Last Updated: 2014-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
76 participants
INTERVENTIONAL
2008-05-31
2008-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Duloxetine Delayed-Release Capsules, 60 mg
Duloxetine
Duloxetine Delayed-Release Capsules 60 mg
Cymbalta
Cymbalta® 60 mg capsule of Eli Lilly and Company
Cymbalta®
60 mg capsule of Eli Lilly and Company
Interventions
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Duloxetine
Duloxetine Delayed-Release Capsules 60 mg
Cymbalta®
60 mg capsule of Eli Lilly and Company
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Screened within 21 days prior to administration of first dose of study drug
3. Having a BMI between 18.5 and 24.9 weight in kg/ height2 in meter
4. Be able to communicate effectively with study personnel
5. 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
2. Have significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG \& X-ray recordings.
3. Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system, diabetes, psychosis or any other body system.
4. History or presence of bronchial asthma.
5. Use of enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication.
6. History of drug dependence, recent history of alcoholism or of moderate alcohol use.
7. 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.
8. 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.
9. A positive hepatitis screen (includes subtypes A, B, C \& E)
10. A positive test result for HIV antibody and/or syphilis (RPR/VDRL).
11. 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.
12. Female volunteers demonstrating a positive pregnancy screen
13. Female volunteers who are currently breast-feeding
14. Female volunteers not willing to use contraception during the study
18 Years
45 Years
ALL
Yes
Sponsors
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Dr. Reddy's Laboratories Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Mayur Soni, MBBS
Role: PRINCIPAL_INVESTIGATOR
BA Research India Ltd
Locations
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BA Research India Ltd
Ahmedabad, Gujarat, India
Countries
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Other Identifiers
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BA085908801
Identifier Type: -
Identifier Source: org_study_id