Two Way Bioequivalence Study Under Fed Conditions

NCT01217801 | Completed Phase 1 Results

• 1 other identifier: OND/CR/021/08-09/01906
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the single dose bioequivalence of Ondansetron ODFS 8mg with Zofran ODT® (Containing Ondansetron 8 mg) in healthy, male and female adult, human study participants under fed conditions. The purpose is to monitor clinical status, adverse events, laboratory investigations and to assess relative safety and tolerance of ondansetron formulations under fed conditions.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Area Under Plasma Concentration

  Calculation of the AUC-Time Curve will be conducted to determine bio-equivalence.

  Day 1 and Day 7

Study Arms (2)

Ondansetron (ODFS)

EXPERIMENTAL

single dose of Ondansetron Orally Dissolving Filmstrip 8 mg

Drug: Ondansetron (ODFS)

Zofran (ODT)

ACTIVE COMPARATOR

Single dose of Zofran (Ondansetron) ODT Orally Disintegrating Tablets 8 mg

Drug: Ondansetron (ODT)

Interventions

Ondansetron (ODFS) DRUG

Ondansetron Orally Dissolving Filmstrip Ondansetron (ODFS)

Also known as: Zuplenz

Ondansetron (ODFS)

Ondansetron (ODT) DRUG

Ondansetron Orally Disintegrating Tablet Ondanestron (ODT)

Also known as: Zofran

Zofran (ODT)

Eligibility Criteria

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

You may qualify if:

• provide written informed consent.
• healthy adult within 18-45 years of age (inclusive).
• Body mass index of ≥ 18.5 kg/m2 and ≤ 25 kg/m2, with body weight not less than 50 kg.
• systolic blood pressure with upper limit of less than 140 mmHg and lower limit of more than or equal to 90 mm Hg.
• normal health as determined by medical history and physical examination performed within 15 days prior to the dosing of period 1.
• Normal ECG, chest X-ray and vital signs.
• If study volunteer is a female and is of child bearing potential practicing an acceptable method of birth control for the duration of the study.

You may not qualify if:

• The study participants were excluded based on the following criteria:
• incapable of understanding the informed consent.
• history of hypersensitivity or idiosyncratic reaction to study drug or any other related drug.
• evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function
• volunteers with a history of tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma .
• smokes regularly more than ten cigarettes daily
• taken over the counter or prescribed medications
• history of any psychiatric illness, which may impair the ability to provide written, informed consent or full participation.
• history of alcohol or substance abuse within the last 5 years.
• clinically significant abnormal values of laboratory parameters.
• positive urine screen for drugs of abuse at the time of admission check-in for each period.

Sponsors & Collaborators

• MonoSol Rx: lead

Study Sites (1)

Vimta VHS Research Centre

Adyār, Chenni, 600 113, 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

Results Point of Contact

• Title: Medical Affairs
• Organization: Par Pharmaceutical

DrugInfo@strativapharma.com

800-828-9393

Study Officials

• Sudershan Vishwanath

  Vimta VHS Research Centre

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: October 7, 2010
• First Posted: October 8, 2010
• Study Start: October 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: May 2, 2017
• Results First Posted: May 2, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)