Relative Bioavailability Study Of Two Lincomycin Hydrochloride Hard Gelatinous Capsule

Relative Bioavailability Study Of Two Lincomycin Hydrochloride Hard Gelatinous Capsule 500 Mg Formulations, In Healthy Volunteers Using Formulations (Frademicina®) Manufactured By Pfizer Laboratories Ltd

To assess the relative bioavailability of two different batches of Frademicina® drug product, containing 500 mg lincomycin hydrocloride, manufactured by Pfizer Laboratories Ltd. The formulations' comparative bioavailability after oral administration will be assessed based on the statistical comparisons of the relevant pharmacokinetic parameters, obtained from the drug concentrations in the blood. The lincomycin hydrocloride concentration will be measured by a proper and validated analytical method.

Study Overview

• Status: Completed
• Conditions: Bacterial Infections
• Intervention / Treatment: Drug: Lincomycin

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo
    • Campinas, Sao Paulo, Brazil, 13012-000
      • Pfizer Investigational Site
    • Campinas, Sao Paulo, Brazil, 13012-431
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men.
• Women who are not pregnant nor nursing.
• Age between 18 and 50 years-old.
• Body mass index ≥ 19 and ≤ 28,5.
• Good health conditions or with no significant diseases, under judgement of the legally qualified professional, according to the rules defined in the Protocol, and based on the following assessments: clinical history, pressure and pulse measurements, physical and psychological examination, ECG and complementary laboratorial tests.
• Ability to understand the nature and the objective of the trial, including the risks and adverse effects and, agreeing to cooperate with the investigator and to act according to the requirements of the whole assay, which will be confirmed through the signature of the Free Informed Consent.

Exclusion Criteria:

• Known hypersensitivity to the study drug (lincomycin hydrocloride) or to compounds chemically related.
• History or presence of hepatic, gastrointestinal diseases or other conditions that may interfere with the absorption, distribution, excretion or metabolism process of the drug.
• History of hepatic, renal, pulmonary, gastrointestinal, epileptic, hematological or psychiatric condition; of hypo or hypertension from any etiology that require pharmacological treatment; history or had myocardial infarction, angina and/or cardiac insufficiency.
• Electrocardiographic findings non-recommended for the enrollment in the trial, by investigator's criteria.
• Results of the laboratory tests are out of the normal range, according to the standards of this protocol, unless they are considered clinically irrelevant by the investigator.
• He/She is a smoker.
• Drinks more than 05 cups of coffee or tea per day.
• History of alcohol or drug abuse.
• Use of regular medication within 02 weeks prior to the beginning of the treatment and to the assessment date; or use of any medication within a week, except for contraceptive medications.
• Hospitalization for any reason within 08 weeks prior to the beginning of the first treatment period of this trial and to the assessment date.
• Treatment within 03 months prior to the trial with any drug with known toxic potential on primary organs.
• Enrollment to any experimental trial or use of any experimental drug within 06 months prior to the beginning of this trial and to the assessment date.
• Donation or loss of 450 mL or more of blood within 03 months that precede the trial or donation higher than 1500 mL within the 12 months between the beginning of the clinical trial and the assessment date.
• Consumption of inducing and/or inhibiting enzymatic drugs (CYP450 - hepatic), toxic to organ or with long half-life period, within 04 weeks prior to the beginning of the trial.
• Consumption of alcohol within 48 hours preceding the enrollment to the trial and during the clinical trial.
• Consumption of food and beverages that contained grapefruit up to 07 days prior to each trial period.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lincomycin - Active Comparative - Hard Gelatin Capsule	Drug: Lincomycin; Single Dose Hard Gelatin Capsule - oral - 500 mg; Other Names: Lincomycin Hydrocloride
Experimental: Lincomycin - Study Drug - Hard Gelatin Capsule	Drug: Lincomycin; Single Dose Hard Gelatin Capsule - oral - 500 mg; Other Names: Lincomycin Hydrocloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUC [0-t]Area under the curve of concentration vs. time, from time 0 (zero) up to the time of the last observed concentration above the limit of quantification, calculated by the trapezium rules.	1 week
Cmax Maximum reached concentration, based on the experimental data, obtained directly from the curve concentration vs. time;	1 week

Secondary Outcome Measures

Outcome Measure	Time Frame
AUC [0-¥]Area under the curve of drug concentration versus time, from time 0 (zero) extrapolated to the infinite, calculated as AUC [0-¥] = AUC [0-t] + Ct/Ke, in which Ct is the last concentration determined above the limit of	1 week
quantification.	1 week
Ke Terminal First Order Elimination Constant, estimated by the angular coefficient of the linear regression, calculated by the Least Square Method, from the natural logarithms of concentration vs. time to the last four values of concentration (or at	1 week
least three) above the limit of quantification.	1 week
T½ Half-life time, calculated as ln (2) / Ke.	1 week
Adverse events and vital signs.	1 week

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: January 27, 2010
• First Submitted That Met QC Criteria: January 27, 2010
• First Posted (Estimate): January 29, 2010

Study Record Updates

• Last Update Posted (Estimate): April 26, 2011
• Last Update Submitted That Met QC Criteria: April 25, 2011
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Bioequivalence; Lincomycin Hydrocloride
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Bacterial Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Lincomycin
• Other Study ID Numbers: B1601001; STPh40/09