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Relative Bioavailability Study Of Two Lincomycin Hydrochloride Hard Gelatinous Capsule

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01058824
First received: January 27, 2010
Last updated: April 25, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Bacterial Infections
Drug: Lincomycin
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Cmax Maximum reached concentration, based on the experimental data, obtained directly from the curve concentration vs. time; [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • quantification. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • least three) above the limit of quantification. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • T½ Half-life time, calculated as ln (2) / Ke. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Adverse events and vital signs. [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]

Enrollment: 36
Study Start Date: April 2009
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lincomycin - Active Comparative - Hard Gelatin Capsule Drug: Lincomycin
Single Dose Hard Gelatin Capsule - oral - 500 mg
Other Name: Lincomycin Hydrocloride
Experimental: Lincomycin - Study Drug - Hard Gelatin Capsule Drug: Lincomycin
Single Dose Hard Gelatin Capsule - oral - 500 mg
Other Name: Lincomycin Hydrocloride

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01058824

Locations
Brazil
Pfizer Investigational Site
Campinas, Sao Paulo, Brazil, 13012-000
Pfizer Investigational Site
Campinas, Sao Paulo, Brazil, 13012-431
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01058824     History of Changes
Other Study ID Numbers: B1601001, STPh40/09
Study First Received: January 27, 2010
Last Updated: April 25, 2011
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Pfizer:
Bioequivalence
Lincomycin Hydrocloride

Additional relevant MeSH terms:
Bacterial Infections
Lincomycin
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014