To Evaluate the Food Effect and the Absorption Profile of Ibuprofen Controlled-Release Tablets 600 mg in Comparison to the Reference Standard Ibuprofen Tablets in Normal Healthy Volunteers

NCT03418805 | Terminated Phase 1 FDA Drug

• 1 other identifier: OVEIBUZ20151221
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the food effect of Ibuprofen CR Tablets 600 mg (IBUCR), and its bioavailability comparison versus 3 doses of the reference arms including Advil® Ibuprofen Tablets 200 mg (IBUAdv) and Motrin® IB Ibuprofen Tablets 200 mg (IBUMot) in normal healthy volunteers.

Conditions

Pain Control

Keywords

Ibuprofen; Controlled-Release; pain control; Healthy Volunteers; Food Effect

Outcome Measures

Primary Outcomes (3)

• Area under the curve from time zero to the time of the last quantifiable plasma concentration of the period (AUC0-last)

  The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation) of AUC0-last within \[0.8, 1.25\] range will be used to determine the result of bioequivalence.

  1 month

• Area under the curve from time zero to infinity (AUC0-inf)

  The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation) of AUC0-inf within \[0.8, 1.25\] range will be used to determine the result of bioequivalence.

  1 month

• Peak concentration at each treatment period (Cmax,tp)

  The 90% CI for the geometric mean ratios (i.e., antilog-transformation for 90% CI of difference with log transformation) of Cmax,tp within \[0.8, 1.25\] range will be used to determine the result of bioequivalence.

  1 month

Secondary Outcomes (11)

• Peak concentration of the first dosing (Cmax)

  1 month

• Time to reach peak concentration of the first dosing (Tmax)

  1 month

• Terminal half-life (T1/2)

  1 month

• Mean residence time (MRT)

  1 month

• The maximum ibuprofen plasma concentration within 1 hour after the first dose administration (Cmax0-1h)

  0.5h and 1h post-dose

Study Arms (4)

Ibuprofen CR Tablet 600 mg-fasting

EXPERIMENTAL

One tablet of IBUCR 600 mg under fasting condition

Drug: Ibuprofen CR Tablets 600 mg

Ibuprofen CR Tablet 600 mg-fed

EXPERIMENTAL

One tablet of IBUCR 600 mg under fed condition

Drug: Ibuprofen CR Tablets 600 mg

Advil Ibuprofen table 200 mg-fasting

ACTIVE COMPARATOR

IBUAdv with a 4-hour dosing interval for 3 tablets (3×200 mg, q4h) under fasting condition

Drug: Advil Ibuprofen table 200 mg

Motrin IB Ibuprofen Tablets 200 mg-fasting

ACTIVE COMPARATOR

IBUMot with a 4-hour doing interval for 3 tablets (3×200 mg, q4h) under fasting condition

Drug: Motrin IB Ibuprofen Tablets 200 mg

Interventions

Advil Ibuprofen table 200 mg DRUG

Administration of the comparator drug: Three tablets (dosing at a 4-hour interval, q4h) of reference ibuprofen standard products, followed by 24 hours after the first dose administration.

Also known as: Advil® Ibuprofen Immediate-Release Tablet 200 mg

Advil Ibuprofen table 200 mg-fasting

Motrin IB Ibuprofen Tablets 200 mg DRUG

Administration of the comparator drug: Three tablets (dosing at a 4-hour interval, q4h) of reference ibuprofen standard products, followed by 24 hours after the first dose administration.

Also known as: Motrin® IB Ibuprofen Tablets 200 mg

Motrin IB Ibuprofen Tablets 200 mg-fasting

Ibuprofen CR Tablets 600 mg DRUG

Administration of the investigational product: Single oral dose of IBUCR, followed by 28 and 32 hours after the dose administration for fasted and fed studies, respectively

Also known as: Ibuprofen Controlled-Release Tablet 600 mg

Ibuprofen CR Tablet 600 mg-fasting; Ibuprofen CR Tablet 600 mg-fed

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects are 20 years of age or older.
• Subjects whose body mass index (BMI) at screening is within a range of ≧18.5 kg/m2 and \<25.0 kg/m2.
• BMI = Body Weight (kg) / \[Height (m)\]2 And body weight is not less than 50 kg and 45 kg for males and females, respectively.
• Subject's medical history shows no contraindication to the test medications (hypersensitivity to ibuprofen or any component of test and reference products).
• Subjects who are judged to be in good health by the investigator based upon the results of physical examinations (PEs), chest X-ray (within 180 days prior to the first dose of the study) and routine laboratory tests.
• The female subject shows negative pregnancy test results within 30 days prior to the first dose of the study.
• The Subject did not take any of the following medications in the specified durations:
• Any medication within 14 days prior to the first dose of the study
• Any enzyme inducer or inhibitor within 30 days prior to the first dose of the study
• Subject understood and has signed the written informed consent form.

You may not qualify if:

• Subjects with any properly diagnosed disease within 30 days prior to the first dose of the study.
• Subjects with a clinically significant hematological, endocrine, cardiovascular, hepatic, renal, gastrointestinal, and/or pulmonary disorder; subjects with any predisposing condition that might interfere with the absorption, distribution, metabolism and excretion of drugs; subjects who has had any previous gastrointestinal surgery, except appendectomy if performed \>90 days prior to the first dose of the study
• Subjects who require treatment with any medications, either prescription or non-prescription (excluding vitamins and food supplements), within 30 days prior to the first dose of the study
• Subjects who have received any known hepatic or renal clearance-altering agents (e.g., erythromycin, cimetidine, barbiturates, phenothiazine, clarithromycin, trolearndomycin, ketoconazole, miconazole, fluconazole, itraconazole) for a period of up to 30 days prior to the first dose of the study
• The subject had participated in investigational drug trials and took any investigational drug within 60 days prior to the first dose of the study.
• The subject had blood donation more than 250 and 500 mL within 60 and 90 days, respectively prior to the first dose of the study.
• The subject had a history of drug abuse or alcohol abuse.
• Subjects cannot stop smoking and caffeine-intakes for 48 hours prior to the first dose of the study and during the entire study period.
• Subjects who are pregnant or lactating
• For enrollment of female subjects with child-bearing potential, the subject must be practicing sexual abstinence or be using and willing to continue to use a medically acceptable form of birth control for at least 30 days prior to screening (that period will extend to 3 months for oral contraceptive use) and for at least 30 days after the last dose of study drug. For a subject to be considered not to be of child-bearing potential, she must have been amenorrheic for at least 2 years, or must have had a hysterectomy, a bilateral tubal ligation, and/or a bilateral oophorectomy (as determined by the medical history). The male partner of a female study subject with childbearing potential must use a condom and ensure that his partner uses a suitable method of contraception as outlined above.
• Subjects who are inappropriate to participate in this study, as judged by the medical investigator or sub-investigator
• Subjects with any contraindication to the use of test medications
• Subjects who are carriers of hepatitis B virus, hepatitis C virus, or are syphilis (STS) positive, or human immunodeficiency virus (HIV) positive

Sponsors & Collaborators

• Overseas Pharmaceuticals, Ltd.: lead
• Virginia Contract Research Organization Co., Ltd.: collaborator

Study Sites (1)

Tri-Service General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: February 1, 2018
• Study Start: December 11, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)