Bioequivalence Study of Sertraline Hydrochloride Tablets 100 mg Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01267396
First received: December 27, 2010
Last updated: January 10, 2012
Last verified: January 2012

December 27, 2010
January 10, 2012
September 2006
September 2006   (final data collection date for primary outcome measure)
Bioequivalence based on Cmax and AUC parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01267396 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Bioequivalence Study of Sertraline Hydrochloride Tablets 100 mg Under Fasting Conditions
Open Label, Balanced, Randomized, Two Treatment, Two Sequence, Two Period, Single-dose, Crossover Oral Bioequivalence Study of Sertraline Hydrochloride 100 mg Tablets (Dr. Reddy's Laboratories Limited, India) With the Reference Formulation ZOLOFT® 100 mg Tablet (Pfizer, USA)Under Fasting Conditions in Healthy Human Adult Subjects.

The objective of this study was to compare and evaluate the single-dose oral bioavailability of the test formulation of Sertraline Hydrochloride 100 mg tablets (Dr. Reddy's Laboratories Limited) with the reference formulation ZOLOFT® 100 mg Tablet (Pfizer)under fasting conditions in healthy adult human subjects.

Open Label, Balanced, Randomized, Two Treatment, Two Sequence, Two Period, Single-dose, Crossover, Oral Bioequivalence Study of Sertraline Hydrochloride 100 mg Tablets (Dr. Reddy's Laboratories Limited, India) With the Reference Formulation ZOLOFT® 100 mg Tablet (Pfizer, USA)Under Fasting Conditions in Healthy Human Adult Subjects. 32 healthy, adult, human male subjects were enrolled in the study and all the subjected completed all the periods.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
Drug: Sertraline
Sertraline Hydrochloride Tablets 100 mg
Other Name: Zoloft
  • Experimental: Sertraline Hydrochloride tablets 100 mg
    Sertraline Hydrochloride tablets 100 mg of Dr.Reddy's Laboratories Limited
    Intervention: Drug: Sertraline
  • Active Comparator: Zoloft 100 mg Tablets
    Zoloft 100 mg Tablets of Pfizer
    Intervention: Drug: Sertraline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
October 2006
September 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Healthy human subjects ages 18 and 45 years (including both).
  2. Subjects weight within the normal range according to normal values for the body mass index (18.5 to 24.9 kg/m2) with minimum of 50 kg weight.
  3. Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable normal rane.
  4. Subjects having normal 12-lead electrocardiogram (ECG)
  5. Subjects having normal chest X-Ray (P/A view)
  6. Subjects having negative urine screen for drugs of abuse(including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
  7. Subjects having negative alcohol breath test
  8. Subjects willing to adhere to the protocol requirements and to provide written informed consent.

For Female Subjects:

  1. Female 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 devise(IUD) or abstinence, or
  2. Postmenopausal for at least 1 year or
  3. Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject.

Exclusion Criteria:

  1. Hypersensitivity to sertraline hydrochloride or related class of drugs.
  2. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological neurological or psychiatric disease or disorder.
  3. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
  4. History or presence of significant alcoholism or drug abuse in the past one year.
  5. History or presence of significant smoking (more than 10 cigarettes day) or consumption of tobacco products.
  6. History or presence of significant asthma, urticaria or other allergic reactions.
  7. History or presence of significant gastric and/or duodenal ulceration.
  8. History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
  9. History or presence of cancer
  10. History or presence of significant easy bruising or bleeding
  11. History or presence of significant recent trauma
  12. Subjects who have been on an abnormal diet(for whatever reason) during the four weeks preceding the study.
  13. Difficulty with donating blood
  14. Difficulty in swallowing solids like tablets or capsules
  15. Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg
  16. Diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
  17. Pulse rate less than 50/minute or more than 100/minute
  18. Oral temperature less than 95ºF or more than 98.6ºF.
  19. Respiratory rate less than 12/minute or more than 20/minute
  20. Use of any prescribed medication during last two weeks or OTC medical products during the last week prior to initiation or study
  21. Major illness during 3 months before screening
  22. Participation in a drug research study within past 3 months
  23. Donation of blood in the past 3 months before screening.

For Female Subjects:

Female subjects who are pregnant or who are able (women with child bearing potential) to become pregnant during the study were not allowed to participate.

Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
NCT01267396
06-VIN-103
No
Sr. Director- Research & Development, Dr. Reddy's Laboratories Limited
Dr. Reddy's Laboratories Limited
Not Provided
Principal Investigator: Damesh Domadia, MBBS, M.D Veeda Clinical Research (P) Ltd
Dr. Reddy's Laboratories Limited
January 2012

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