Bioequivalence Study of Sertraline Hydrochloride Tablets 100 mg in Fed Conditions

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01267383
First received: December 27, 2010
Last updated: January 10, 2012
Last verified: January 2012
  Purpose

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 fed conditions in healthy adult human subjects.


Condition Intervention Phase
Healthy
Drug: Sertraline
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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 Fed Conditions in Healthy Human Adult Subjects.

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bioequivalence based on Cmax and AUC parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: September 2006
Study Completion Date: October 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sertraline Hydrochloride tablets 100 mg
Sertraline Hydrochloride tablets 100 mg of Dr.Reddy's Laboratories Limited
Drug: Sertraline
Sertraline Hydrochloride Tablets 100 mg
Other Name: Zoloft
Active Comparator: Zoloft 100 mg Tablets
Zoloft 100 mg Tablets of Pfizer
Drug: Sertraline
Sertraline Hydrochloride Tablets 100 mg
Other Name: Zoloft

Detailed Description:

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 Fed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01267383

Locations
India
Veeda Clinical Research (P) Ltd
Ambawadi, Ahmedabad, India, 380 015
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Damesh Domadia, MBBS, M.D Veeda Clinical Research (P) Ltd
  More Information

No publications provided

Responsible Party: Sr. Director- Research & Development, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01267383     History of Changes
Other Study ID Numbers: 06-VIN-102
Study First Received: December 27, 2010
Last Updated: January 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Dr. Reddy's Laboratories Limited:
Bioequivalence
Sertraline
crossover

Additional relevant MeSH terms:
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014