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Bioequivalence Study Comparing Rifampicin In A Fixed-Dose Combination (Rifampicin+Isoniazid, Myrin© 2) And The Reference Drug (Rifampicin, Rimactane®)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01311505
First received: February 15, 2011
Last updated: June 21, 2012
Last verified: June 2012

February 15, 2011
June 21, 2012
April 2011
May 2011   (final data collection date for primary outcome measure)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUC [0-t]) [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hours (hrs) post-dose ] [ Designated as safety issue: No ]
    AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose ] [ Designated as safety issue: No ]
  • Change in area under the plasma concentration-time profile from time zero to different time points (AUC(0-t)) of rifampicin [ Time Frame: Day 1: baseline and 1,2,3,4,6,8,10 hours post-dose ] [ Designated as safety issue: No ]
  • Change in maximum plasma concentration (Cmax) of rifampicin [ Time Frame: Day 1: baseline and at 1,2,3,4,6,8,10 hours post-dose ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01311505 on ClinicalTrials.gov Archive Site
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-∞]) [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose ] [ Designated as safety issue: No ]
    AUC (0-∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-t) plus AUC (t-∞).
  • Plasma Decay Half-life (t1/2) [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose ] [ Designated as safety issue: No ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
  • Extrapolated Area Under the Curve (AUC Percent [%] Extrapolated) [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 6, 8 and 10 hrs post-dose ] [ Designated as safety issue: No ]
    AUC%extrapolated is the extrapolated area under the plasma concentration time profile following the last measured concentration. It is calculated as (AUC [0-∞] minus AUC[0-10])*100/ AUC (0-∞), where AUC (0-∞) = Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time (0-∞) and AUC(0-10) = area under the plasma concentration time-curve from zero (pre-dose) to the last quantifiable concentration.
  • Change in time passed since administration at which the maximum plasma concentration occurs (Tmax) of rifampicin [ Time Frame: Day 1: baseline and at 1,2,3,4,6,8,10 hours post-dose ] [ Designated as safety issue: No ]
  • Change in area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUC0-inf) (if data permit) of rifampicin [ Time Frame: Day 1: baseline and at 1,2,3,4,6,8,10 hours post-dose ] [ Designated as safety issue: No ]
  • Change in terminal elimination half-life (t1/2) (if data permit) of rifampicin [ Time Frame: Day 1: baseline and at 1,2,3,4,6,8,10 hours post-dose ] [ Designated as safety issue: No ]
  • Change in extrapolated area under the plasma concentration time profile following the last measured concentration (AUC%extrapolated) of rifampicin [ Time Frame: Day 1: baseline and at 1,2,3,4,6,8,10 hours post-dose ] [ Designated as safety issue: No ]
  • Number of subjects with abnormal safety laboratory tests [ Time Frame: Screening ] [ Designated as safety issue: Yes ]
  • Number of subjects with abnormal safety laboratory tests [ Time Frame: Follow-up (Visit 4 - 1 wk after Period 2) if there are findings that needs to be followed-up ] [ Designated as safety issue: Yes ]
  • Change from baseline supine blood pressure [ Time Frame: Screening; Day 0; Day 1-10 hrs post-dose; Follow-up (1 wk after Period 2) if needs to be followed-up ] [ Designated as safety issue: Yes ]
  • Change from baseline pulse rate [ Time Frame: Screening; Day 0; Day 1-10 hrs post-dose; Follow-up (1 wk after Period 2) if needs to be followed-up ] [ Designated as safety issue: Yes ]
  • Change from baseline oral temperature [ Time Frame: Screening; Day 0; Day 1-10 hrs post-dose; Follow-up (1 wk after Period 2) if needs to be followed-up ] [ Designated as safety issue: Yes ]
  • Change from baseline respiratory rate [ Time Frame: Screening; Day 0; Day 1-10 hrs post-dose; Follow-up (1 wk after Period 2) if needs to be followed-up ] [ Designated as safety issue: Yes ]
  • Number of subjects with Adverse Events [ Time Frame: Day 0 ] [ Designated as safety issue: Yes ]
  • Number of subjects with Adverse Events [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
  • Number of subjects with Adverse Events [ Time Frame: Follow-up (Visit 4 - 1 week after Period 2) ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Bioequivalence Study Comparing Rifampicin In A Fixed-Dose Combination (Rifampicin+Isoniazid, Myrin© 2) And The Reference Drug (Rifampicin, Rimactane®)
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Tuberculosis
  • Drug: Myrin© 2 (Rifampicin + Isoniazid)
    Two (2) fixed-dose combination tablets each containing Rifampicin 150 mg and Isoniazid 75 mg
    Other Name: Myrin© 2 (Pfizer Inc.)
  • Drug: Rimactane® (Rifampicin)
    One (1) capsule of Rifampicin 300 mg
    Other Name: Rimactane® (Novartis Sandoz)
  • Active Comparator: A
    Test
    Intervention: Drug: Myrin© 2 (Rifampicin + Isoniazid)
  • Active Comparator: B
    Reference
    Intervention: Drug: Rimactane® (Rifampicin)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
May 2011
May 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Male
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Philippines
 
NCT01311505
B3801001
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP