Bioequivalence Study of Sorafenib Tablet and Nexavar

NCT02599337 | Completed Phase 1

• 1 other identifier: 150230
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, open-label, 3-way reference replicated crossover bioequivalence study of sorafenib 200 mg tablet and nexavar (reference) following a 200 mg dose in healthy subjects under fasting conditions.

Conditions

Fasting

Keywords

bioequivalence

Outcome Measures

Primary Outcomes (1)

• Assessment of the bioequivalence of sorafenib tablet (Test)and Nexavar(Reference), on day 4.

  Compare the rate and extent of absorption of sorafenib 200 mg tablet (Test) versus Nexavar (Reference), administered as 1 x 200 mg tablet under fasting conditions. Evaluate whether has the bioequivalence between the Test and the Reference.Criteria as follows: for a primary parameter (AUC0-t, AUC0-inf, or Cmax), if 1. the point estimate of the Test-to-Reference ratio must be within 80.00% 125.00%, and 2. the 95% upper confidence bound for the scaled average bioequivalence criterion must be equal to or less than zero (≤0) to conclude in favor of BE for that parameter.

  96 hours

Secondary Outcomes (1)

• safety: number TEAEs, deaths, SAEs and other significant adverse events

  96 hours

Study Arms (2)

sorafenib

EXPERIMENTAL

Sorafenib is the test product.In period 1, period 2 and period 3, 12 of 36 Subjects were given Single oral dose (1 x 200 mg) sarofenib.

Drug: Nexavar; Drug: Sorafenib

Nexavar

ACTIVE COMPARATOR

Nexavar is the reference product.In period 1, period 2 and period 3, 24 of 36 Subjects were given Single oral dose (1 x 200 mg) Nexavar .

Drug: Nexavar; Drug: Sorafenib

Interventions

Nexavar DRUG

Single oral dose (1 x 200 mg) sorafenib or Nexavar in each period. No food were allowed from at least 10 hours before dosing until at least 4 hours after dosing. Except for water given with study medication, no fluids were allowed from 1 hour before dosing until 1 hour post-dose.

Nexavar; sorafenib

Sorafenib DRUG

Single oral dose (1 x 200 mg) sorafenib or Nexavar in each period. No food were allowed from at least 10 hours before dosing until at least 4 hours after dosing. Except for water given with study medication, no fluids were allowed from 1 hour before dosing until 1 hour post-dose.

Also known as: sarafenib

Nexavar; sorafenib

Eligibility Criteria

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

You may qualify if:

• Male or non-childbearing potential female, which includes post-menopausal female (absence of menses for 12 months prior to drug administration, bilateral oophorectomy or hysterectomy with bilateral oophorectomy at least 6 months prior to drug administration) or surgically sterile female (hysterectomy or tubal ligation at least 6 months prior to drug administration), smoker (no more than 25 cigarettes or equivalent daily) or non-smoker, ≥18 and ≤65 years of age, with BMI \>18.5 and \<30.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
• Healthy as defined by:
• the absence of clinically significant history of neurological, endocrinal, cardiovascular, pulmonary, hematological, immunologic, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
• lipase within normal laboratory ranges
• Capable of consent.

You may not qualify if:

• Any clinically significant abnormality or abnormal laboratory test results found during medical screening or positive test for hepatitis B, hepatitis C, or HIV found during medical screening.
• Positive urine drug screen at screening.
• History of allergic reactions to sorafenib, any of the excipients or other related drugs.
• Use of any drugs known to induce or inhibit CYP3A4 metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, etc.; examples of inhibitors: HIV antivirals, clarithromycin, ciprofloxacin, gestodene, etc. within 30 days prior to the first study drug administration.
• Positive pregnancy test at screening.
• Any reason which, in the opinion of the Qualified Investigator, would prevent the subject from participating in the study.
• Clinically significant electrocardiogram (ECG) abnormalities (QTc \>450) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
• History of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week \[1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol\]).
• History of significant drug abuse within one year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine \[PCP\], and crack) within 1 year prior to screening.
• Participation in a clinical trial involving the administration of an investigational or marketed drug within 30 days (90 days for biologics) prior to the first dosing or concomitant participation in an investigational study involving no drug administration.
• Use of medication other than topical products without significant systemic absorption:
• prescription medication within 14 days prior to the first dosing;
• over-the-counter products including natural health products (e.g. food supplements and herbal supplements) within 7 days prior to the first dosing, with the exception of the occasional use of acetaminophen (up to 2 g daily);
• a depot injection or an implant of any drug within 3 months prior to the first dosing.
• Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first dosing.

Sponsors & Collaborators

• Yabao Pharmaceutical Group: lead

Study Sites (1)

Inventiv Health Clinique Inc.

Québec, Quebec, G1P 0A2, Canada

Location

MeSH Terms

Conditions

Fasting

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Richard Larouche, MD

  employee

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: November 6, 2015
• Study Start: July 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 6, 2015

Record last verified: 2015-07

Locations

CA (1)