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Bioavailability Study of Duloxetine Delayed-Relase Capsules 60 mg Under Fed Condition

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ClinicalTrials.gov Identifier: NCT02291341
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

Tracking Information
First Submitted Date  ICMJE November 11, 2014
First Posted Date  ICMJE November 14, 2014
Last Update Posted Date November 14, 2014
Study Start Date  ICMJE May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2014)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bioavailability Study of Duloxetine Delayed-Relase Capsules 60 mg Under Fed Condition
Official Title  ICMJE Single Dose Crossover Comparative Bioavailability Study of Duloxetine Delayed-Release Capsules 60 mg in Healthy Adult Human Subjects Under Fed Conditions
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 fed 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 fed conditions
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Duloxetine
    Duloxetine Delayed-Release Capsules 60 mg
    Other Name: Cymbalta
  • Drug: Cymbalta®
    60 mg capsule of Eli Lilly and Company
Study Arms  ICMJE
  • Experimental: Duloxetine Delayed-Release Capsules, 60 mg
    Duloxetine Delayed-Release Capsules, 60 mg of Dr. Reddys Laboratories Limited
    Intervention: Drug: Duloxetine
  • Active Comparator: Cymbalta
    Cymbalta® 60 mg capsule of Eli Lilly and Company
    Intervention: Drug: Cymbalta®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 13, 2014)
76
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. The subjects should be healthy human between 18 and 45 years.
  2. The subjects should be screened within 21 days prior to the administration of first dose of the study drug.
  3. The subjects should have a BMI between 18.5 and 24.9 weight in kg/ height2 in meter.
  4. The subjects should be able to communicate effectively with study personnel.
  5. The subjects should 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. The subjects who have a history of allergic responses to Duloxetine or other related drugs.
  2. The subjects who have significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG and X-ray recordings.
  3. The subjects who have 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. The subjects who have a history or presence of bronchial asthma.
  5. The subject who have used enzyme-modifying drugs within 30 days prior to receiving the first dose of study medication.
  6. The subjects who have history of drug dependence, recent history of alcoholism or of moderate alcohol use.
  7. The subjects who are 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 cannot refrain from smoking during study period.
  8. The subjects with a history of difficulty with donating blood or difficulty in accessibility of veins.
  9. The subjects who have donated (1 unit: 350 ml / 450 ml) blood within 90 days prior to receiving the first dose of study medication.
  10. The subjects who have a positive hepatitis screen (includes subtypes A, B, C & E).
  11. The subjects who have a positive test result for HIV antibody and / or syphilis (RPR/VDRL).
  12. The subject who receives an investigational product, or has participated in a drug research study within a period of 90 days prior to the first dose of the study medication administration.
  13. Female volunteers demonstrating a positive pregnancy screen.
  14. Female volunteers who are currently breast-feeding.
  15. Female volunteers not willing to use contraception during the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02291341
Other Study ID Numbers  ICMJE BA0859089-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Reddy's Laboratories Limited
Study Sponsor  ICMJE Dr. Reddy's Laboratories Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dr.Ronak Modi, MBBS BA Research India Ltd
PRS Account Dr. Reddy's Laboratories Limited
Verification Date July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP