Bioequivalence Study for Ondansetron Hydrochloride Tablets 8 mg Under Fasting Condition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01511705
Recruitment Status : Completed
First Posted : January 19, 2012
Last Update Posted : January 19, 2012
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Ondansetron Hydrochloride Phase 1

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  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : October 2006
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: Ondansetron Hydrochloride 8 mg (Dr. Reddy's Laboratories)
Active Comparator: Zofran Tablets 8 mg
Zofran Tablets 8 mg of GlaxoSmithKline
Drug: Ondansetron Hydrochloride
Zofran Tablets 8 mg

Primary Outcome Measures :
  1. Area unde curve (AUC) [ Time Frame: 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 ]

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01511705

Vimta Labs Limited
Hyderabad, Andhra Pradesh, India, 500 051
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Principal Investigator: Dr. I.S Gandhi Vimta Labs Limited

Responsible Party: Dr. Reddy's Laboratories Limited Identifier: NCT01511705     History of Changes
Other Study ID Numbers: 3873/06-07
First Posted: January 19, 2012    Key Record Dates
Last Update Posted: January 19, 2012
Last Verified: October 2006

Keywords provided by Dr. Reddy's Laboratories Limited:

Additional relevant MeSH terms:
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents