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This is a bioequivalence study to evaluate the bioequivalence of RIN 150 against individual reference drugs in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | RIN 150 contains 150 rifampicin and 75 mg isoniazid |
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| Reference | Active Comparator | Individual references of rifampicin and isoniazid |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RIN 150 | Drug | Each subject will receive a single oral dose of 4 fixed dose combination tablets (RIN 150) each contains 150 rifampicin and 75 mg isoniazid. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) was reported for rifampicin and isoniazid. | 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 |
| Maximum Observed Plasma Concentration (Cmax) | Cmax was reported for rifampicin and isoniazid. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] | 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 - ∞). | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinically Significant Changes in Vital Signs | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Singapore | Singapore | 188770 | Singapore |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | RIN 150 First, Then Rifampicin and Isoniazid | Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contained 150 milligram [mg] rifampicin and 75 mg isoniazid) on Day 1 in first intervention period, followed by single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in second intervention period. A washout period of at least 7 days was maintained between each intervention period. |
| FG001 | Rifampicin and Isoniazid First, Then RIN 150 | Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in first intervention period followed by single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in second intervention period. A washout period of at least 7 days was maintained between each intervention period. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention Period 1 |
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| Washout Period 1 (7 Days) |
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| Intervention Period 2 |
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Analysis population included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | Includes all participants randomized to receive RIN 150 first and rifampicin and isoniazid first. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) was reported for rifampicin and isoniazid. | Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | (nanogram*hour) per milliliter (ng*h/mL) | 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 |
|
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Safety analysis population included all participants who received at least 1 dose of study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RIN 150 | Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mouth ulceration | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| reference drugs | Drug | Each subject will receive a single oral dose of 4 x 150 mg rifampicin capsules and 3 x 100 mg isoniazid capsules. |
|
| Plasma Decay Half-Life (t1/2) | Plasma decay half life (t1/2) was reported for rifampicin and isoniazid. | 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 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Tmax was reported for rifampicin and isoniazid. | 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 |
| Screening up to Day 2 of intervention period 2 |
| Number of Participants With Laboratory Test Abnormalities | 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. | Screening up to Day 2 of intervention period 2 |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG001 | Rifampicin and Isoniazid | Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods. |
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| Primary | Maximum Observed Plasma Concentration (Cmax) | Cmax was reported for rifampicin and isoniazid. | Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 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 |
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| Secondary | Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] | 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 - ∞). | Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, n=participants in the treatment group who were evaluable for this measure for specified drug of each group with reportable AUC (0 - ∞) values, respectively. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 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 |
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| Secondary | Plasma Decay Half-Life (t1/2) | Plasma decay half life (t1/2) was reported for rifampicin and isoniazid. | Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. Here, n=participants in the treatment group who were evaluable for this measure for specified drug of each group with reportable t½ values, respectively. | Posted | Mean | Standard Deviation | hour | 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 |
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| Secondary | Time to Reach Maximum Observed Plasma Concentration (Tmax) | Tmax was reported for rifampicin and isoniazid. | Pharmacokinetic parameter analysis set included all treated participants who had at least 1 estimated pharmacokinetic parameter of primary interest. | Posted | Median | Full Range | hour | 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 |
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| Other Pre-specified | Number of Participants With Clinically Significant Changes in Vital Signs | 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. | Safety analysis set consisted of all participants who received at least 1 dose of study medication. | Posted | Number | participants | Screening up to Day 2 of intervention period 2 |
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| Other Pre-specified | Number of Participants With Laboratory Test Abnormalities | 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. | Safety analysis set consisted of all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | participants | Screening up to Day 2 of intervention period 2 |
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| 0 |
| 27 |
| 27 |
| 27 |
| EG001 | Rifampicin and Isoniazid | Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods. | 0 | 27 | 26 | 27 |
| Nausea | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Catheter site haematoma | General disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Catheter site pain | General disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA v15.0 | Non-systematic Assessment |
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| Lip injury | Injury, poisoning and procedural complications | MedDRA v15.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Chromaturia | Renal and urinary disorders | MedDRA v15.0 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Natural log transformed Cmax of isoniazid was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% CIs for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale. | Ratio of adjusted geometric means | 107.58 | 2-Sided | 90 | 96.07 | 120.47 | No | Superiority or Other |
| Natural log transformed AUC(0 - ∞) of isoniazid was analyzed using mixed effects model with sequence,period and treatment as fixed effects and participant within sequence as random effect.The adjusted mean differences and 90% confidence intervals(CIs) for the differences were exponentiated to provide estimates of ratio of adjusted geometric means(Test/Reference) and 90% CIs for the ratios,where FDC tablet were test and single drugs were reference.Values were back-transformed from the log scale. | Ratio of adjusted geometric means | 102.41 | 2-Sided | 90 | 98.76 | 106.19 | No | Superiority or Other |