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Trial record 97 of 5971 for:    zero

A Bioequivalence Study Comparing A Fixed Dose Combination Formulation, Rin 150 And Individual Reference Drugs In Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02014272
Recruitment Status : Completed
First Posted : December 18, 2013
Results First Posted : July 16, 2014
Last Update Posted : July 16, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This is a bioequivalence study to evaluate the bioequivalence of RIN 150 against individual reference drugs in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: RIN 150 Drug: reference drugs Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open Label, Single Dose, 2-Way Cross-Over Randomized Bioequivalence Study Comparing A Fixed Dose Combination Formulation, Rin 150 (Contains 150 Mg Rifampicin And 75 Mg Isoniazid Per Tablet) To An Equivalent Dose Of Single Drug Reference Preparations Of Rifampicin And Isoniazid Following Oral Administration In Healthy Adults Under Fasting Conditions
Study Start Date : September 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Test
RIN 150 contains 150 rifampicin and 75 mg isoniazid
Drug: RIN 150
Each subject will receive a single oral dose of 4 fixed dose combination tablets (RIN 150) each contains 150 rifampicin and 75 mg isoniazid.

Active Comparator: Reference
Individual references of rifampicin and isoniazid
Drug: reference drugs
Each subject will receive a single oral dose of 4 x 150 mg rifampicin capsules and 3 x 100 mg isoniazid capsules.




Primary Outcome Measures :
  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1 ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) was reported for rifampicin and isoniazid.

  2. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1 ]
    Cmax was reported for rifampicin and isoniazid.


Secondary Outcome Measures :
  1. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] [ Time Frame: 0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1 ]
    AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞) was reported for rifampicin and isoniazid. It is obtained from AUC (0 - t) plus AUC (t - ∞).

  2. Plasma Decay Half-Life (t1/2) [ Time Frame: 0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1 ]
    Plasma decay half life (t1/2) was reported for rifampicin and isoniazid.

  3. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0 hour (pre-dose), 0.25, 0.5, 0.75, 1, 1.33 (1 hour 20 minutes), 1.67 (1 hour 40 minutes), 2, 2.33 (2 hours 20 minutes), 2.67 (2 hours 40 minutes), 3, 3.5, 4, 6, 8, 12, 16, 24 hours post-dose on Day 1 ]
    Tmax was reported for rifampicin and isoniazid.


Other Outcome Measures:
  1. Number of Participants With Clinically Significant Changes in Vital Signs [ Time Frame: Screening up to Day 2 of intervention period 2 ]
    Criteria for clinical significant change in vital signs: systolic blood pressure (BP) less than (<) 90 millimeters of mercury (mmHg), diastolic BP <50 mmHg, supine and sitting heart rate <40 beats per minute (bpm) or greater than (>) 120 bpm, standing and erect heart rate <40 bpm or >140 bpm. Maximum change from baseline in systolic BP >=30 mmHg, maximum change from baseline in diastolic BP >=20 mmHg. Participants who met the criteria were reported.

  2. Number of Participants With Laboratory Test Abnormalities [ Time Frame: Screening up to Day 2 of intervention period 2 ]
    Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (less than [<] 0.8*lower limit of normal[LLN]); leucocytes (<0.6/ greater than [>] 1.5*limit of reference range [LRR]); platelets (<0.5/>1.75*LRR); neutrophils, lymphocytes (<0.8/>1.2*LRR); eosinophils, basophils, monocytes (>1.2*upper LN [ULN]); bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (>3*ULN); creatinine, urea (>1.3*ULN); fasting glucose (<0.6 />1.5*LRR); uric acid (>1.2*ULN); sodium (<0.95/>1.05*LRR); potassium, calcium, chloride, bicarbonate (<0.9/>1.1*LRR); albumin, total protein (<0.8/>1.2*LRR); creatine kinase (>2.0*ULN); urine red blood cells (RBCs), urine white blood cells (WBCs) (>=20 high-powered field). Total number of participants with any laboratory abnormalities was reported.



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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male or female, 21 to 55 years of age, body weight no less than 55 kg, with a signed and dated informed consent document and is willing and able to comply with all 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, allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing), positive Hepatitis B surface antigen or HIV serology results;
  • Pregnant or nursing female;
  • History or active tuberculosis;
  • Participated in investigational drug studies within 3 months;
  • Used prescription or nonprescription drugs within 7 days or 5 half-lives.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02014272


Locations
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Singapore
Pfizer Investigational Site
Singapore, Singapore, 188770
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02014272     History of Changes
Other Study ID Numbers: B3801003
First Posted: December 18, 2013    Key Record Dates
Results First Posted: July 16, 2014
Last Update Posted: July 16, 2014
Last Verified: June 2014

Keywords provided by Pfizer:
Bioequivalence
RIN 150
Healthy volunteers

Additional relevant MeSH terms:
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Rifampin
Isoniazid
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents