Bioavailability Study of Duloxetine Delayed-Release Capsules 60 mg Under Fasting Condition

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02291367
• Date of registration: 11/11/2014
• Prospective Registration: No
• Primary sponsor: Dr. Reddy's Laboratories Limited
• Public title: Bioavailability Study of Duloxetine Delayed-Release Capsules 60 mg Under Fasting Condition
• Scientific title: Single Dose Crossover Comparative Bioavailability Study of Duloxetine Delayed-Release Capsules 60 mg in Healthy Adult Human Subjects Under Fasting Conditions
• Date of first enrolment: May 2008
• Target sample size: 76
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02291367
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

India

Contacts

• Name: Mayur Soni, MBBS
• Affiliation: BA Research India Ltd

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Be healthy human between 18 and 45 years

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:

1. History of allergic responses to Duloxetine or other related drugs.

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



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Cymbalta®

Drug: Duloxetine

Primary Outcome(s)

Area under curve (AUC) [Time Frame: 1.0, 2.0,3.0, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 9.0, 10.0, 11.0, 12.0, 24.0, 36.0, 48.0,60.0 and 72.0 hours post dose]

Secondary ID(s)

BA085908801

Source(s) of Monetary Support

Please refer to primary and secondary sponsors