Bioequivalence Study for Ondansetron Hydrochloride Tablets 8 mg Under Fasting Condition

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01511705
First received: January 13, 2012
Last updated: January 18, 2012
Last verified: October 2006
  Purpose

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


Condition Intervention Phase
Healthy
Drug: Ondansetron Hydrochloride
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: October 2006
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01511705

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

No publications provided

Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01511705     History of Changes
Other Study ID Numbers: 3873/06-07
Study First Received: January 13, 2012
Last Updated: January 18, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Dr. Reddy's Laboratories Limited:
Bioequivalence
Ondansetron
crossover

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

ClinicalTrials.gov processed this record on October 20, 2014