Bioequivalence Study of Sertraline Hydrochloride Tablets 100 mg in Fed Conditions

NCT ID: NCT01267383

Last Updated: 2012-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2006-10-31

Brief Summary

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.

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sertraline Hydrochloride tablets 100 mg

Sertraline Hydrochloride tablets 100 mg of Dr.Reddy's Laboratories Limited

Group Type: EXPERIMENTAL

Sertraline

Intervention Type: DRUG

Sertraline Hydrochloride Tablets 100 mg

Zoloft 100 mg Tablets

Zoloft 100 mg Tablets of Pfizer

Group Type: ACTIVE_COMPARATOR

Sertraline

Intervention Type: DRUG

Sertraline Hydrochloride Tablets 100 mg

Interventions

Sertraline

Sertraline Hydrochloride Tablets 100 mg

Intervention Type: DRUG

Other Intervention Names

Zoloft

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. Reddy's Laboratories Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Dr. Reddy's Laboratories Limited

Principal Investigators

Damesh Domadia, MBBS, M.D

Role: PRINCIPAL_INVESTIGATOR

Veeda Clinical Research (P) Ltd

Locations

Veeda Clinical Research (P) Ltd

Ambawadi, Ahmedabad, India

Countries

India

Other Identifiers

06-VIN-102

Identifier Type: -

Identifier Source: org_study_id