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Relative Bioavailability Study Of Two Lincomycin Hydrochloride Hard Gelatinous Capsule

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Campinas, Sao Paulo, 13012-000 Brazil
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bacterial Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT01058824
Pfizer
Completed
Relative Bioavailability Study Of Two Lincomycin Hydrochloride Hard Gelatinous Capsule

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