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Relative Bioavailability Study Of Two Lincomycin Hydrochloride Hard Gelatinous Capsule

Last updated on November 21, 2019

FOR MORE INFORMATION
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.
Show details

- 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.
Show details

- 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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Descriptive Information
Brief Title  ICMJE Relative Bioavailability Study Of Two Lincomycin Hydrochloride Hard Gelatinous Capsule
Official Title  ICMJE Relative Bioavailability Study Of Two Lincomycin Hydrochloride Hard Gelatinous Capsule 500 Mg Formulations, In Healthy Volunteers Using Formulations (Frademicina®) Manufactured By Pfizer Laboratories Ltd
Brief SummaryTo 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Bacterial Infections
Intervention  ICMJE Drug: Lincomycin
Single Dose Hard Gelatin Capsule - oral - 500 mg
Other Name: Lincomycin Hydrocloride
Study Arms  ICMJE
  • Active Comparator: Lincomycin - Active Comparative - Hard Gelatin Capsule
    Intervention: Drug: Lincomycin
  • Experimental: Lincomycin - Study Drug - Hard Gelatin Capsule
    Intervention: Drug: Lincomycin
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2011)
36
Original Actual Enrollment  ICMJE
 (submitted: January 27, 2010)
49
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion DateApril 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01058824
Other Study ID Numbers  ICMJE B1601001
STPh40/09
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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