A Bioequivalence (BE) Study Comparing The Commericializable And Clinical Formulations Of PF-00299804

Healthy Volunteers Clinical Trial

Official title:

A Phase 1 Open-Label Study Of Pf-00299804 In Healthy Volunteers To Demonstrate The Bioequivalence Of The Proposed Commercializable Formulation Administered As One 45-Mg Tablet Relative To Three 15-Mg Clinical Formulation Tablets

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01313793
• Other study ID #: A7471022
• Status: Completed
• Phase: Phase 1
• First received: February 8, 2011
• Last updated: June 27, 2011
• Start date: April 2011
• Est. completion date: May 2011

Study information

• Verified date: June 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The study will determine if bioequivalence can be claimed between the proposed commericializable formulation and the current clinical formulation. Specifically, if the 90% confidence intervals of the ratio for Area under the curve (AUC) and maximum concentration (CMax) are within the 80%-125% guidance limits.

Description:

A bioequivalence (BE) study between two formulations of PF-00299804.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy subjects including males between the ages of 18 and 55 years and/or females of non childbearing potential between the ages of 18 and 55 years. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG or clinical laboratory tests).

• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

• An informed consent document signed and dated by the subject.

• Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

• Evidence or history of clinically significant dermatologic, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

• Any condition possibly affecting drug absorption (eg, gastrectomy).

• A positive urine drug screen.

• Use of tobacco- or nicotine- containing products (or a positive urine drug cotinine test).

• History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.

• Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study medication.

• 12 lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec at Screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject's eligibility.

• Pregnant or nursing females and females of childbearing potential including those with tubal ligation. To be considered for enrollment, women of 45 to 55 years of age who are postmenopausal (defined as being amenorrheic for at least 2 years) must have confirmatory FSH test results at Screening.

• Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication. Herbal supplements and hormone replacement therapy must be discontinued at least 28 days prior to the first dose of study medication. Depo Provera must be discontinued at least 6 months prior to the first dose of study medication. As an exception, acetaminophen/paracetamol may be used at doses of less than 1 g/day. Limited use of non prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by the sponsor.

• Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.

• History of sensitivity to heparin or heparin-induced thrombocytopenia.

• Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.

• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Treatment A-B
Subjects to receive 3 X 15 mg tablets of the clinical formulation in first period then 1 x 45 mg tablet of the commericializable formulation in 2nd period.
• Treatment B-A
Subjects to receive 1 x 45 mg tablet of the commericializable formulation in first period then 3X 15 mg tablets of the clinical formulation in 2nd period.

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma AUCinf of of PF 00299804		6-8 weeks	No
Primary	AUClast of PF 00299804		6-8 weeks	No
Primary	Cmax of PF 00299804		6-8 weeks	No
Secondary	Plasma AUCinf of PF 00299804.		6-8 weeks	No
Secondary	CL/F of PF 00299804.		6-8 weeks	No
Secondary	Tmax of PF 00299804.		6-8 weeks	No
Secondary	tlast of PF 00299804.		6-8 weeks	No
Secondary	t1/2 of PF 00299804.		6-8 weeks	No
Secondary	Plasma AUCinf of PF-05199265		6-8 weeks	No
Secondary	AUClast of PF-05199265		6-8 weeks	No
Secondary	Cmax of PF-05199265		6-8 weeks	No
Secondary	Tmax of PF-05199265		6-8 weeks	No
Secondary	tlast of PF-05199265		6-8 weeks	No
Secondary	Safety laboratory tests, physical examination, concomitant medication and adverse event monitoring		6-8 weeks	Yes

External Links

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