Clinical trial NCT02291367: Bioavailability Study of Duloxetine Delayed-Release Capsules 60 mg Under Fasting Condition
Official title: Single Dose Crossover Comparative Bioavailability Study of Duloxetine Delayed-Release Capsules 60 mg in Healthy Adult Human Subjects Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
First posted: 2014-11-14
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 60 mg) in healthy, adult, human subjects under fasting conditions and to monitor safety of subjects

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 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

Primary outcomes:
measure: Area under curve (AUC)
timeFrame: 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 outcomes:
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: BA Research India Ltd
state: Gujrat
Study officials:
affiliation: BA Research India Ltd
name: Mayur Soni, MBBS
role: PRINCIPAL_INVESTIGATOR
References: