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

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ClinicalTrials.gov Identifier: NCT02291367
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : November 14, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Duloxetine Drug: Cymbalta® Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Dose Crossover Comparative Bioavailability Study of Duloxetine Delayed-Release Capsules 60 mg in Healthy Adult Human Subjects Under Fasting Conditions
Study Start Date : May 2008
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Duloxetine Delayed-Release Capsules, 60 mg Drug: Duloxetine
Duloxetine Delayed-Release Capsules 60 mg
Other Name: Cymbalta

Active Comparator: Cymbalta
Cymbalta® 60 mg capsule of Eli Lilly and Company
Drug: Cymbalta®
60 mg capsule of Eli Lilly and Company




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291367


Locations
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India
BA Research India Ltd
Ahmedabad, Gujrat, India, 380 054
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
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Principal Investigator: Mayur Soni, MBBS BA Research India Ltd

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Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT02291367     History of Changes
Other Study ID Numbers: BA085908801
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: November 14, 2014
Last Verified: July 2008

Additional relevant MeSH terms:
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Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents