Bioequivalence Study for Ondansetron Hydrochloride Tablets 8 mg Under Fasting Condition

Open Label, Balanced, Randomized, Two-treatment, Two-period, Two Sequence, Single Dose, Crossover, Oral Bioequivalence Study of Ondansetron Hydrochloride Tablets 8 mg With Zofran® (Containing Ondansetron Hydrochloride Dihydrate) Tablets 8 mg in Healthy, Adult, Human Subjects Under Fasting Condition.

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Ondansetron Hydrochloride; Drug: Ondansetron Hydrochloride

Detailed Description

The study was an open label, balanced, randomized, two-treatment, two-period, two sequence,single dose, crossover, oral bioequivalence study of Ondansetron Hydrochloride tablets 8 mg of Dr. Reddy's Laboratories Limited, India comparing with that of Zofran® (containing Ondansetron Hydrochloride Dihydrate) tablets 8 mg of GlaxoSmithKline, USA in healthy, adult, human subjects under fasting condition. 26 subjects are enrolled in the study, and 24 subjects are completed the study.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Andhra Pradesh
    • Hyderabad, Andhra Pradesh, India, 500 051
      • Vimta Labs Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

or

• 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.

Exclusion Criteria:

• 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.
• Female volunteers who are not negative in pregnancy test
• All female subjects were to be screened for pregnancy at check in of each study period. Subjects with positive or inconclusive results were to be withdrawn from the study.
• Female volunteers who are currently breast feeding.
• Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study were not to be allowed to participate. Female subjects of child bearing potential must either abstain form sexual intercourse or use a reliable barrier method (e.g condom, IUD) or contraception during the course of the study (first dosing until last blood collection) or they were not to be allowed to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ondansetron Hydrochloride Tablets 8 mg; Ondansetron Hydrochloride Tablets 8 mg of Dr. Reddy's Laboratories Limited	Drug: Ondansetron Hydrochloride; Ondansetron Hydrochloride Tablets 8 mg; Other Names: Ondansetron Hydrochloride 8 mg (Dr. Reddy's Laboratories); Drug: Ondansetron Hydrochloride; Zofran Tablets 8 mg
Active Comparator: Zofran Tablets 8 mg; Zofran Tablets 8 mg of GlaxoSmithKline	Drug: Ondansetron Hydrochloride; Ondansetron Hydrochloride Tablets 8 mg; Other Names: Ondansetron Hydrochloride 8 mg (Dr. Reddy's Laboratories); Drug: Ondansetron Hydrochloride; Zofran Tablets 8 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): October 1, 2006
• Study Completion (Actual): October 1, 2006

Study Registration Dates

• First Submitted: January 13, 2012
• First Submitted That Met QC Criteria: January 18, 2012
• First Posted (Estimate): January 19, 2012

Study Record Updates

• Last Update Posted (Estimate): January 19, 2012
• Last Update Submitted That Met QC Criteria: January 18, 2012
• Last Verified: October 1, 2006

More Information

Terms related to this study

• Keywords: Bioequivalence; Ondansetron; crossover
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; Anti-Anxiety Agents; Antipruritics; Ondansetron
• Other Study ID Numbers: 3873/06-07