Bioequivalence Study of Ibuprofen D, Oral Suspension, 200 mg/5ml and Nurofen®, Oral Suspension 100 mg/5 ml in Healthy Volunteers Under Fasting Conditions

NCT03561558 | Completed Phase 1

• 1 other identifier: FRM-03-IBU/21/11/17
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To demonstrate bioequivalence of single dose test formulation of Ibuprofen,oral suspension 200 mg/5 ml (containing ibuprofen 200 mg) of Pharmtechnology LLC, Republic of Belarus with reference Nurofen® for Children, oral suspension 100 mg / 5 ml (containing ibuprofen 100 mg) of "Reckitt Benckiser Healthcare International Ltd, .", UK in normal, healthy, adult, human subjects under fasting conditions.To monitor adverse events and ensure the safety

Conditions

Healthy

Keywords

Bioequivalence

Outcome Measures

Primary Outcomes (2)

• Primary pharmacokinetic parameter for S-enantiomer of ibuprofen

  Peak Plasma Concentration (Cmax)

  8 days

• Primary pharmacokinetic parameter for S-enantiomer of ibuprofen

  Area under the plasma concentration versus time curve from time 0 to the last measured concentration (AUC0-t)

  8 days

Secondary Outcomes (6)

• Safety and tolerability of the investigational products (testing and reference)

  22 days

• Secondary pharmacokinetic parameter for S-enantiomer of ibuprofen

  8 days

• Secondary pharmacokinetic parameter for S-enantiomer of ibuprofen

  8 days

• Secondary pharmacokinetic parameter for S-enantiomer of ibuprofen

  8 days

• Secondary pharmacokinetic parameter for S-enantiomer of ibuprofen

  8 days

Study Arms (2)

Ibuprofen D, oral suspension

EXPERIMENTAL

Ibuprofen oral suspension, 200 mg/ 5 ml is the test product. In period 1 and period 2, 15 of 30 subjects will be given single oral dose (5 ml containing 200 mg of ibuprofen) of suspension.

Drug: Ibuprofen D

Nurofen® for Children, oral suspension

ACTIVE COMPARATOR

Nurofen® for Children oral suspension, 100 mg/ 5 ml is the reference product. In period 1 and period 2, 15 of 30 subjects will be given single oral dose (10 ml containing 200 mg of ibuprofen) of suspension.

Drug: Nurofen® for Children

Interventions

Ibuprofen D DRUG

Ibuprofen D, oral suspension, 200 mg / 5ml, manufactured by LLC Pharmtechnology, Belarus

Ibuprofen D, oral suspension

Nurofen® for Children DRUG

Nurofen® for Children, Oral Suspension, 100 mg / 5 ml, marketed by Reckitt Benckiser Healthcare International Ltd, UK

Nurofen® for Children, oral suspension

Eligibility Criteria

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

You may qualify if:

• Healthy adult human subjects, aged between 18 to 45 years.
• Subjects with Body Mass Index (BMI) 18.5 to 30 kg/m2.
• Female subjects with a negative pregnancy test.
• Non-lactating females.
• If subject is a female and is of child bearing potential, she should be practicing an acceptable non-hormonal method of birth control for the duration of the study(at least 14 days before the start of the study, throughout the study and 14 days after the completion of the study), such as a combination of male condom and diaphragm with spermicide.
• If subject is a male and and has a female partner of child bearing potential, he should be practicing an acceptable method of birth control for the duration of the study(at least 14 days before the start of the study, throughout the study and 14 days after the completion of the study), such as a combination of male condom and spermicide (double barrier method).
• Subjects having no clinically significant medical history and no clinically significant abnormalities in general physical examination, laboratory assessments, 12-lead ECG, chest X-Ray or vital signs.
• Subjects are able to understand the requirements of the study, to sign a written informed consent, and also to accept all the restrictions imposed during the course of the study, and to agree to return for the required investigations.

You may not qualify if:

• Subjects with a known history of allergic disorders.
• Subjects with a known history of drug hypersensitivity to ibuprofen d or any excipients of the formulation.
• Subjects with a known history of drug intolerance.
• Subjects with history of psychiatric disorders.
• Subjects with history of epilepsy, seizures, other neurological disorders.
• Subjects on a low sodium diet for 2 weeks before the start study, or on any special diet (for example, vegetarian, vegan) or follow a special lifestyle (night shifts,extreme physical work).
• Use of hormonal contraceptives either oral or implants within 6 months prior to first period dosing.
• Female subjects of child bearing potential who have had an unprotected sexual intercourse with an unsterilized male sexual partner within 30 days before the start of the study
• Use of any xanthine-containing food or beverages (tea, coffee, chocolates, soft drinks like cola, etc.) for at least 72 hours prior to the start of the study.
• Use of citrus fruits (including grapefruit and grapefruit juice) and cranberries (including juices,etc.) for at least 14 days prior to the start of the study.
• Subjects with a history of disorders of cardiovascular, bronchopulmonary, neuroendocrine system, and also the gastrointestinal tract, liver, kidney and blood.
• Subjects with a history of other disorders that, at the discretion of the Principal Investigator, can affect absorption, distribution, metabolism or excretion of both drugs or increase the risk of adverse effects.
• Subjects with a history of surgical interventions on the gastrointestinal tract except for appendectomy.
• Subjects with a history acute infectious illnesses within 4 weeks prior to the start of the study.
• Subjects with abnormalities in resting heart rate (\>80 beats/min or \<60 beats/min), blood pressure either hypotensive episode (systolic blood pressure \<100 mmHg or diastolic blood pressure \<70 mmHg) or hypertension (systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥90 mmHg), in ECG

Sponsors & Collaborators

• Pharmtechnology LLC: lead
• ClinPharmInvest, LLC: collaborator

Study Sites (1)

State Autonomous Healthcare Facility of the Yaroslavl Region "Clinical Hospital No. 2"

Yaroslavl, Yaroslavl Oblast, 150010, Russia

Location

Study Officials

• Alexander Khokhlov, Professor

  ClinPharmInvest, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study is an open label study; the subjects and the investigator will not be blinded towards the identity of the investigational products. However, analysts will be blinded towards identity of investigational products administered.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: June 19, 2018
• Study Start: June 11, 2018
• Primary Completion: June 24, 2018
• Study Completion: June 25, 2018
• Last Updated: November 1, 2018

Record last verified: 2018-06

Locations

RU (1)