Two Way Bioequivalence Study Under Fed Conditions

MonoSol Rx

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Ondansetron (ODFS); Drug: Ondansetron (ODT)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01217801

OND/CR/021/08-09/01906

Details and patient eligibility

About

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.

Full description

An open-label randomized, single oral dose, two way crossover bioequivalence study to compare ondansetron Orally Dissolving FilmStrip (ODFS) 8mg with Zofran Orally Disintegrating Tablets [ODT® (Containing Ondansetron 8 mg)] in 48 healthy, adult, human study participants under fed conditions. Volunteers who signed the consent form and showed their willingness to participate in the study were enrolled. Volunteers who satisfied the inclusion and exclusion criteria and found to be healthy on physical examination with laboratory investigation values within reference limits were considered eligible to be admitted into the study. Study participants were fasted for 10 hours prior to dosing in both periods. Dosing was conducted as per the randomization schedule in each period under fed conditions.A washout period of 7 days was observed between the two periods.

Enrollment: 48 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Ondansetron (ODFS)

Experimental group

Description:

single dose of Ondansetron Orally Dissolving Filmstrip 8 mg

Treatment:

Drug: Ondansetron (ODFS)

Zofran (ODT)

Active Comparator group

Description:

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

Treatment:

Drug: Ondansetron (ODT)