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Trial record 1 of 1 for:    NCT01399788
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A Bioequivalence Study Comparing A Fixed Dose Combination Formulation Of Myrin P Forte That Contains Rifampicin, Isoniazid, Ethambutol And Pyrazinamide Per Tablet To An Equivalent Dose Of Single Drug Reference Preparations Of Similar Combination Following Oral Administration In Healthy Adults

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ClinicalTrials.gov Identifier: NCT01399788
Recruitment Status : Completed
First Posted : July 22, 2011
Results First Posted : March 16, 2012
Last Update Posted : April 5, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Healthy Volunteers
Interventions Drug: Myrin P Forte
Drug: Single drug references
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Myrin-P Forte First, Then Four Single Drug References Four Single Drug References First, Then Myrin-P Forte
Hide Arm/Group Description Single oral dose of 4 fixed dose combination (FDC) tablets of Myrin-P Forte (each tablet contains 150 milligram (mg) rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide) in first intervention period; and single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in second intervention period. A washout period of at least 1 week was maintained between each period. Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in first intervention period; and single oral dose of 4 FDC tablets of Myrin-P Forte (each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide) in second intervention period. A washout period of at least 1 week was maintained between each period.
Period Title: First Intervention Period
Started 18 18
Completed 17 18
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Period Title: Washout Period (at Least 1 Week)
Started 17 18
Completed 17 18
Not Completed 0 0
Period Title: Second Intervention Period
Started 17 18
Completed 17 18
Not Completed 0 0
Arm/Group Title Entire Study Population
Hide Arm/Group Description Includes participants randomized to receive Myrin-P Forte first and four single drug references first.
Overall Number of Baseline Participants 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants
32.6  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
2
   5.6%
Male
34
  94.4%
1.Primary Outcome
Title Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Hide Description Area under the plasma concentration-time curve from time zero (pre-dose) to the time of last measured concentration (AUClast).
Time Frame 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours (hrs) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period.
Arm/Group Title Myrin-P Forte Four Single Drug References
Hide Arm/Group Description:
Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
Overall Number of Participants Analyzed 36 35
Geometric Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
Rifampicin 79360.0  (29613.0) 77180.0  (20516.0)
Isoniazid 20550.0  (12920.0) 18800.0  (12941.0)
Ethambutol 15070.0  (3298.8) 15170.0  (3119.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Myrin-P Forte, Four Single Drug References
Comments Rifampicin; 32 participants (16 per sequence) provided at least 99% power that 90% confidence interval (CI) for ratio of test to reference for AUClast lie within acceptance region of 80% - 125%. An intra-subject coefficient of variation (CV) estimate of approximately 14.5% for AUClast was used for this power calculation. Natural log transformed AUClast was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Means
Estimated Value 103.81
Confidence Interval (2-Sided) 90%
99.20 to 108.64
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Myrin-P Forte, Four Single Drug References
Comments Isoniazid; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for AUClast lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 12.0% for AUClast was used for this power calculation. Natural log transformed AUClast was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Means
Estimated Value 107.28
Confidence Interval (2-Sided) 90%
101.95 to 112.90
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Myrin-P Forte, Four Single Drug References
Comments Ethambutol; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for AUClast lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 12.9% for AUClast was used for this power calculation. Natural log transformed AUClast was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Means
Estimated Value 99.48
Confidence Interval (2-Sided) 90%
94.92 to 104.25
Estimation Comments [Not Specified]
2.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax)
Hide Description [Not Specified]
Time Frame 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hrs post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period.
Arm/Group Title Myrin-P Forte Four Single Drug References
Hide Arm/Group Description:
Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
Overall Number of Participants Analyzed 36 35
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
Rifampicin 12120.0  (3682.3) 11830.0  (2351.8)
Isoniazid 4418.0  (1619.0) 4237.0  (1658.9)
Ethambutol 2771.0  (825.4) 2865.0  (950.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Myrin-P Forte, Four Single Drug References
Comments Rifampicin: 32 participants (16 per sequence) provided at least 98% power that 90% CI for ratio of test to reference for Cmax lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 18.2% for Cmax was used for this power calculation. Natural log transformed Cmax was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Means
Estimated Value 102.75
Confidence Interval (2-Sided) 90%
95.36 to 110.71
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Myrin-P Forte, Four Single Drug References
Comments Isoniazid; 32 participants (16 per sequence) provided at least 98% power that 90% CI for ratio of test to reference for Cmax lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 18.2% for Cmax was used for this power calculation. Natural log transformed Cmax was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Means
Estimated Value 103.85
Confidence Interval (2-Sided) 90%
92.13 to 117.07
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Myrin-P Forte, Four Single Drug References
Comments Ethambutol; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for Cmax lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 16.0% for Cmax was used for this power calculation. Natural log transformed Cmax was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Means
Estimated Value 99.48
Confidence Interval (2-Sided) 90%
94.92 to 104.25
Estimation Comments [Not Specified]
3.Primary Outcome
Title Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn]) for Pyrazinamide
Hide Description AUClast[dn] = Dose normalized area under the plasma concentration-time curve (AUC[dn]) from time zero (pre-dose) to the time of last measured concentration. It is obtained from AUClast divided by dose and then multiplied by 1500. The test and reference for pyrazinamide were given at different doses, so dose-normalized parameters were used for analysis for adjusting the dose effect on bioequivalence conclusion.
Time Frame 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period.
Arm/Group Title Myrin-P Forte Four Single Drug References
Hide Arm/Group Description:
Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
Overall Number of Participants Analyzed 36 35
Geometric Mean (Standard Deviation)
Unit of Measure: (ng*hr/mL)/mg
453500  (76250) 447900  (82578)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Myrin-P Forte, Four Single Drug References
Comments Pyrazinamide; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for AUClast lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 5.2% for AUClast was used for this power calculation. Natural log transformed AUClast(dn) was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Means
Estimated Value 101.73
Confidence Interval (2-Sided) 90%
99.12 to 104.40
Estimation Comments [Not Specified]
4.Primary Outcome
Title Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) for Pyrazinamide
Hide Description It is obtained from Cmax divided by dose and then multiplied by 1500. The test and reference for pyrazinamide were given at different doses, so dose-normalized parameters were used for analysis for adjusting the dose effect on bioequivalence conclusion.
Time Frame 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period.
Arm/Group Title Myrin-P Forte Four Single Drug References
Hide Arm/Group Description:
Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
Overall Number of Participants Analyzed 36 35
Geometric Mean (Standard Deviation)
Unit of Measure: (ng/mL)/mg
33890.0  (6490.2) 35580.0  (12134.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Myrin-P Forte, Four Single Drug References
Comments Pyrazinamide; 32 participants (16 per sequence) provided at least 99% power that 90% CI for ratio of test to reference for Cmax lie within acceptance region of 80% - 125%. An intra-subject CV estimate of approximately 6.7% for Cmax was used for this power calculation. Natural log transformed Cmax(dn) was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Means
Estimated Value 95.17
Confidence Interval (2-Sided) 90%
88.60 to 102.22
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC[0-∞])
Hide Description 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-∞).
Time Frame 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hrs post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period. Here, 'n' is number of participants who were evaluable for this measure.
Arm/Group Title Myrin-P Forte Four Single Drug References
Hide Arm/Group Description:
Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
Overall Number of Participants Analyzed 36 35
Geometric Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
Rifampicin (n= 36, 35) 80940.0  (34613.0) 78400.0  (22226.0)
Isoniazid (n= 35, 35) 21210.0  (13562.0) 19460.0  (14171.0)
Ethambutol (n= 28, 31) 17150.0  (3362.1) 17050.0  (3378.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Myrin-P Forte, Four Single Drug References
Comments Rifampicin; Natural log transformed AUC(0-∞) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Means
Estimated Value 104.30
Confidence Interval (2-Sided) 90%
99.70 to 109.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Myrin-P Forte, Four Single Drug References
Comments Isoniazid; Natural log transformed AUC(0-∞) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Means
Estimated Value 105.74
Confidence Interval (2-Sided) 90%
100.32 to 111.46
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Myrin-P Forte, Four Single Drug References
Comments Ethambutol; Natural log transformed AUC(0-∞) was analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Means
Estimated Value 100.97
Confidence Interval (2-Sided) 90%
96.28 to 105.88
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0-∞][dn]) for Pyrazinamide
Hide Description AUC [0-∞][dn] = Dose normalized area under the plasma concentration versus time curve (AUC[dn]) from time zero (pre-dose) to extrapolated infinite time (0-∞). It is obtained from AUC (0-∞) divided by dose and then multiplied by 1500. The test and reference for pyrazinamide were given at different doses, so dose-normalized parameters were used for analysis for adjusting the dose effect on bioequivalence conclusion.
Time Frame 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hrs post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period.
Arm/Group Title Myrin-P Forte Four Single Drug References
Hide Arm/Group Description:
Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
Overall Number of Participants Analyzed 36 35
Geometric Mean (Standard Deviation)
Unit of Measure: (ng*hr/mL)/mg
471000  (85153) 464800  (92222)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Myrin-P Forte, Four Single Drug References
Comments Pyrazinamide; Natural log transformed AUC (0 -∞)(dn) was analyzed using mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of Adjusted Means
Estimated Value 101.80
Confidence Interval (2-Sided) 90%
99.24 to 104.43
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Plasma Decay Half-life (t1/2)
Hide Description Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hrs post-dose for rifampicin, isoniazid and ethambutol and additional 36 and 48 hrs post-dose for pyrazinamide
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period. Here, 'n' is number of participants who were evaluable for this measure.
Arm/Group Title Myrin-P Forte Four Single Drug References
Hide Arm/Group Description:
Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
Overall Number of Participants Analyzed 36 35
Mean (Standard Deviation)
Unit of Measure: hr
Rifampicin (n= 36, 35) 3.6630  (1.0477) 3.4290  (0.6938)
Isoniazid (n= 35, 35) 3.7340  (0.9197) 3.9470  (1.1751)
Ethambutol (n= 28, 31) 7.7430  (1.1716) 7.6390  (1.1158)
Pyrazinamide (n= 36, 35) 9.8630  (1.3333) 9.7660  (1.3671)
8.Secondary Outcome
Title Time to Reach Maximum Observed Plasma Concentration (Tmax)
Hide Description [Not Specified]
Time Frame 0 (pre-dose), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hrs post-dose for rifampicin, isoniazid and ethambutol and additional 36 and 48 hrs post-dose for pyrazinamide
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameter analysis population included all randomized and treated participants who had at least 1 of the PK parameters for one of four analytes in at least 1 treatment period.
Arm/Group Title Myrin-P Forte Four Single Drug References
Hide Arm/Group Description:
Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
Overall Number of Participants Analyzed 36 35
Median (Full Range)
Unit of Measure: hr
Rifampicin
2.00
(1.00 to 4.00)
1.50
(1.00 to 3.00)
Isoniazid
1.02
(0.25 to 2.52)
1.00
(0.25 to 3.00)
Ethambutol
2.77
(1.00 to 4.28)
2.48
(1.50 to 4.00)
Pyrazinamide
1.50
(0.25 to 3.02)
1.50
(0.25 to 6.00)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Myrin-P Forte Four Single Drug References
Hide Arm/Group Description Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide. Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
All-Cause Mortality
Myrin-P Forte Four Single Drug References
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Myrin-P Forte Four Single Drug References
Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/35 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Myrin-P Forte Four Single Drug References
Affected / at Risk (%) Affected / at Risk (%)
Total   34/36 (94.44%)   31/35 (88.57%) 
Gastrointestinal disorders     
Abdominal pain * 1  1/36 (2.78%)  0/35 (0.00%) 
Diarrhoea * 1  1/36 (2.78%)  0/35 (0.00%) 
Nausea * 1  1/36 (2.78%)  0/35 (0.00%) 
General disorders     
Catheter site swelling * 1  1/36 (2.78%)  0/35 (0.00%) 
Pyrexia * 1  1/36 (2.78%)  0/35 (0.00%) 
Infections and infestations     
Oral herpes * 1  1/36 (2.78%)  0/35 (0.00%) 
Upper respiratory tract infection * 1  1/36 (2.78%)  0/35 (0.00%) 
Investigations     
Blood glucose increased * 1  1/36 (2.78%)  1/35 (2.86%) 
Cardiac murmur functional * 1  0/36 (0.00%)  1/35 (2.86%) 
Nervous system disorders     
Dizziness * 1  0/36 (0.00%)  1/35 (2.86%) 
Headache * 1  1/36 (2.78%)  0/35 (0.00%) 
Renal and urinary disorders     
Chromaturia * 1  32/36 (88.89%)  31/35 (88.57%) 
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain * 1  0/36 (0.00%)  1/35 (2.86%) 
Rhinorrhoea * 1  1/36 (2.78%)  0/35 (0.00%) 
Skin and subcutaneous tissue disorders     
Dermatitis contact * 1  1/36 (2.78%)  1/35 (2.86%) 
Drug eruption * 1  1/36 (2.78%)  1/35 (2.86%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01399788    
Other Study ID Numbers: B3801002
First Submitted: July 13, 2011
First Posted: July 22, 2011
Results First Submitted: February 22, 2012
Results First Posted: March 16, 2012
Last Update Posted: April 5, 2017