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Bioequivalence of fixed-dose combination RIN®-150 to each reference drug in loose combination
H F Wang1, R Wang1, M O'Gorman1
1Pfizer Inc., Groton, Connecticut, USA.
Summary
The fixed-dose combination tablet RIN-150, containing rifampicin and isoniazid, is bioequivalent to individual drug formulations. This study confirms its suitability for tuberculosis treatment.
Area of Science:
- Pharmacokinetics and Drug Development
- Clinical Pharmacology
- Tuberculosis Therapeutics
Background:
- RIN-150 is a fixed-dose combination (FDC) tablet with rifampicin (RMP) 150 mg and isoniazid (INH) 75 mg.
- Developed as a potential treatment for tuberculosis (TB).
Purpose of the Study:
- To establish bioequivalence of RMP and INH from RIN-150 compared to individual reference products.
- To support the use of this fixed-dose combination for TB management.
Main Methods:
- Randomized, open-label, single-dose, two-way crossover study design.
- Subjects received RIN-150 or loose combination reference products under fasting conditions.
- Bioequivalence assessed by comparing peak plasma concentration (Cmax) and area under the curve (AUC) for RMP and INH.
Main Results:
- Bioequivalence demonstrated for both rifampicin and isoniazid components.
- Adjusted geometric mean ratios for RMP Cmax and AUC were within bioequivalence limits.
- Adjusted geometric mean ratios for INH Cmax and AUC were within bioequivalence limits.
- Both formulations were well-tolerated.
Conclusions:
- The RIN-150 fixed-dose combination tablet is bioequivalent to separate rifampicin and isoniazid formulations.
- RIN-150 is a suitable alternative for tuberculosis treatment, offering convenience.
- Confirms the pharmaceutical equivalence of the FDC for RMP and INH delivery.
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