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Relative Bioavailability Study Of Two Lincomycin Hydrochloride Hard Gelatinous Capsule

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bacterial Infections

Intervention: Lincomycin (Drug); Lincomycin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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.

Clinical Details

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

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

Primary outcome:

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.

Cmax Maximum reached concentration, based on the experimental data, obtained directly from the curve concentration vs. time;

Secondary outcome:

AUC [0-Â¥]Area under the curve of drug concentration versus time, from time 0 (zero) extrapolated to the infinite, calculated as AUC [0-Â¥] = AUC [0-t] + Ct/Ke, in which Ct is the last concentration determined above the limit of

quantification.

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

least three) above the limit of quantification.

T½ Half-life time, calculated as ln (2) / Ke.

Adverse events and vital signs.

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

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

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

Additional Information

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

Starting date: April 2009
Last updated: April 25, 2011

Page last updated: August 23, 2015

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