Bioequivalence Study for Ondansetron Hydrochloride Tablets 8 mg Under Fasting Condition

NCT01511705 | Completed Phase 1

• 1 other identifier: 3873/06-07
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label, balanced, randomized, two-treatment, two-period, two sequence,single dose, crossover, oral bioequivalence study.

Conditions

Healthy

Keywords

Bioequivalence; Ondansetron; crossover

Outcome Measures

Primary Outcomes (1)

• Area unde curve (AUC)

  First one was within 1 hour prior to drug administration (0.0) and others at 0.33,0.67,1,1.33, 1.67, 2, 2.5, 3, 3.5,4,6,9,12,15,18 and 24 hours

Study Arms (2)

Ondansetron Hydrochloride Tablets 8 mg

EXPERIMENTAL

Ondansetron Hydrochloride Tablets 8 mg of Dr. Reddy's Laboratories Limited

Drug: Ondansetron Hydrochloride

Zofran Tablets 8 mg

ACTIVE COMPARATOR

Zofran Tablets 8 mg of GlaxoSmithKline

Drug: Ondansetron Hydrochloride

Interventions

Ondansetron Hydrochloride DRUG

Ondansetron Hydrochloride Tablets 8 mg

Also known as: Ondansetron Hydrochloride 8 mg (Dr. Reddy's Laboratories)

Ondansetron Hydrochloride Tablets 8 mg

Eligibility Criteria

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

You may qualify if:

• Subjects who provide written informed consent.
• Subjects who were healthy adults within 18 and 45 years of age (both inclusive).
• Body mass index of ≥ 18 kg/m2 and ≤ 25 kg/m2, with body weight not less than 50 kg.
• Subjects who had normal health as determined by medical history and physical examination performed within 15 days prior to the dosing of period I.
• Had normal ECG, Chest X-ray and vital signs
• Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.
• If subject is a female volunteer and 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.
• is postmenopausal for at least 1 year or
• is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)
• Each female subject were supposed to undergo a urine pregnancy test to check-in for period-I, period-II and post study.

You may not qualify if:

• Subjects incapable of understanding the informed consent.
• Subjects BP ≤ 9060 mm/Hg or BP ≥ 140/90 mm/Hg.
• History of hypersensitivity or idiosyncratic reaction to ondansetron or any other related drugs.
• Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function. Subjects with a history of tuberculosis, epilepsy, asthma(during past 5 years), diabetes, psychosis or glaucoma were not eligible for the study.
• Regular smoker who smokes more than ten cigarettes daily and has difficulty in abstaining from smoking for the duration of each study period.
• Subjects who has taken over the counter or prescribed medications, including any enzyme modifying drugs or any systemic medication with the past 30 days prior to dosing in Period-I.
• History of any psychiatric illness, which may impair the ability to provide written informed consent.
• Subjects who have a history of alcohol or substance abuse within the last 5 years.
• Subjects with clinically significant abnormal values of laboratory parameters.
• Subjects who have participated in any other clinical investigation using experimental drug or had bled more than 350 mL in the past 3 months.
• Subjects who are unable to or likely to be non-complaint with protocol requirements or restrictions.
• Any subject in whom ondansetron is contraindicated for medical reasons.
• Subjects who are intolerant to venipuncture.
• Subjects with positive urine screen for drugs of abuse. All subjects urine samples assayed for the presence of drugs of abuse at each study period check-in. Subjects who found to have urine concentrations of any of the tested drugs were not allowed to participate.
• Female volunteers who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives with 14 days before dosing.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Vimta Labs Limited

Hyderabad, Andhra Pradesh, 500 051, India

Location

MeSH Terms

Interventions

Ondansetron

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Dr. I.S Gandhi

  Vimta Labs Limited

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 13, 2012
• First Posted: January 19, 2012
• Study Start: October 1, 2006
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: January 19, 2012

Record last verified: 2006-10

Locations

IN (1)