Bioequivalence Study Comparing Rifampicin In A Fixed-Dose Combination (Rifampicin+Isoniazid, Myrin© 2) And The Reference Drug (Rifampicin, Rimactane®)
NCT01311505
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Healthy male subjects between the ages of 18 and 55 years, inclusive.
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- An informed consent document signed and dated by the subject.
- Subjects willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).
- Any condition possibly affecting drug absorption (e.g., gastrectomy).
- A positive urine drug screen.
- History of regular alcohol consumption exceeding 21 drinks/week (1 drink = 5 ounces
(150 ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of hard liquor)
within 6 months of screening.
- Treatment with an investigational drug within 3 months (or as determined by the local
requirement, whichever is longer) or 5 half-lives preceding the first dose of study
medication.
- 12-lead ECG demonstrating QTc >450 msec at screening. If QTc exceeds 450 msec, the ECG
should be repeated two more times and the average of the three QTc values should be
used to determine the subject's eligibility.
- History of previous treatment for TB or is suspected of suffering from TB.
- Use of prescription or nonprescription drugs and dietary supplements within 7 days or
5 half-lives (whichever is longer) prior to the first dose of study medication. Herbal
medication, herbal supplements and hormone replacement therapy must be discontinued 28
days prior to the first dose of study medication. As an exception, acetaminophen /
paracetamol may be used at doses of less than 1 g/day. Limited use of non-prescription
medications that are not believed to affect subject safety or the overall results of
the study may be permitted on a case-by-case basis following approval by the sponsor.
- Blood donation of approximately 1 pint (500 ml) within 56 days prior to dosing.
- A history of hypersensitivity to any of the study medications or related substances,
or to any of the ingredients used in the study drug formulations.
- Unwilling or unable to comply with the Lifestyle guidelines described in this
protocol.
- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this study.
- Recent history of diarrhea (2 weeks).
- Recent use of oral (2 weeks) or IV (2-3 months) antibiotics to assure normal bowel
flora at study start.
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Descriptive Information | ||||
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Brief Title ICMJE | Bioequivalence Study Comparing Rifampicin In A Fixed-Dose Combination (Rifampicin+Isoniazid, Myrin© 2) And The Reference Drug (Rifampicin, Rimactane®) | |||
Official Title ICMJE | An Open Label, Single Dose, Randomized, Two-Way Cross-Over Bioequivalence Study Comparing Rifampicin In A Fixed-Dose Combination Rifampicin + Isoniazid (Myrin© 2, Pfizer Inc) Tablet With The Reference Drug (Rimactane®, Novartis Sandoz) Capsule In Healthy Filipino Male Subjects | |||
Brief Summary | This study is done to demonstrate bioequivalence of rifampicin component in Myrin© 2 Fixed-Dose Combination Tablet (each contains 75 mg isoniazid and 150 mg rifampicin, Pfizer Inc) with equivalent dose of the reference Rimactane® capsule (each contains 300 mg rifampicin, Novartis Sandoz) in healthy Filipino male subjects. This study also aims to determine the safety and tolerability of Myrin© 2 tablets and Rimactane® capsules in these subjects. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Tuberculosis | |||
Intervention ICMJE |
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Study Arms ICMJE |
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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 | 21 | |||
Original Estimated Enrollment ICMJE | 22 | |||
Actual Study Completion Date ICMJE | May 2011 | |||
Actual Primary Completion Date | May 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Philippines | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01311505 | |||
Other Study ID Numbers ICMJE | B3801001 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | June 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |