Bioequivalence Study of Sertraline Hydrochloride Tablets 100 mg Under Fasting Conditions

NCT01267396 | Completed Phase 1

• 1 other identifier: 06-VIN-103
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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 fasting conditions in healthy adult human subjects.

Conditions

Healthy

Keywords

Bioequivalence; Sertraline; crossover

Outcome Measures

Primary Outcomes (1)

• Bioequivalence based on Cmax and AUC parameters

  3 months

Study Arms (2)

Sertraline Hydrochloride tablets 100 mg

EXPERIMENTAL

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

Drug: Sertraline

Zoloft 100 mg Tablets

ACTIVE COMPARATOR

Zoloft 100 mg Tablets of Pfizer

Drug: Sertraline

Interventions

Sertraline DRUG

Sertraline Hydrochloride Tablets 100 mg

Also known as: Zoloft

Sertraline Hydrochloride tablets 100 mg; Zoloft 100 mg Tablets

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy human subjects ages 18 and 45 years (including both).
• 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.
• Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable normal rane.
• Subjects having normal 12-lead electrocardiogram (ECG)
• Subjects having normal chest X-Ray (P/A view)
• Subjects having negative urine screen for drugs of abuse(including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
• Subjects having negative alcohol breath test
• Subjects willing to adhere to the protocol requirements and to provide written informed consent.
• For Female Subjects:
• 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
• Postmenopausal for at least 1 year or
• Surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject.

You may not qualify if:

• Hypersensitivity to sertraline hydrochloride or related class of drugs.
• History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological neurological or psychiatric disease or disorder.
• Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
• History or presence of significant alcoholism or drug abuse in the past one year.
• History or presence of significant smoking (more than 10 cigarettes day) or consumption of tobacco products.
• History or presence of significant asthma, urticaria or other allergic reactions.
• History or presence of significant gastric and/or duodenal ulceration.
• History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
• History or presence of cancer
• History or presence of significant easy bruising or bleeding
• History or presence of significant recent trauma
• Subjects who have been on an abnormal diet(for whatever reason) during the four weeks preceding the study.
• Difficulty with donating blood
• Difficulty in swallowing solids like tablets or capsules
• Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Veeda Clinical Research (P) Ltd

Ambawadi, Ahmedabad, 380 015, India

Location

MeSH Terms

Interventions

Sertraline

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Damesh Domadia, MBBS, M.D

  Veeda Clinical Research (P) Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 27, 2010
• First Posted: December 28, 2010
• Study Start: September 1, 2006
• Primary Completion: September 1, 2006
• Study Completion: October 1, 2006
• Last Updated: January 11, 2012

Record last verified: 2012-01

Locations

IN (1)