Overview

Bioequivalence Study for Ondansetron Hydrochloride Tablets 8 mg Under Fasting Condition

Status:
Completed
Trial end date:
2006-10-01
Target enrollment:
0
Participant gender:
All
Summary
This is an open label, balanced, randomized, two-treatment, two-period, two sequence,single dose, crossover, oral bioequivalence study.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Dr. Reddy's Laboratories Limited
Treatments:
Ondansetron
Criteria
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.