In ayurveda, black pepper, long pepper, and ginger are collectively known as trikatu, which has been used as a bioenhancer. Carum carvi is one such herbal bioenhancer that has been extensively studied along with antibiotics, antifungals, antivirals, anticancer, anti-inflammatory, antitubercular, antihistaminics. Although, a few recent studies have proved the bioenhancing selleck chemical Imatinib property of C. carvi with antitubercular drugs in animals,[10,11] to the best of our knowledge there is no study evaluating its bioenhancing property in humans. Thus, the present study was undertaken to evaluate the effect of C. carvi extract, a herbal bioenhancer on pharmacokinetics of antitubercular drugs in humans. MATERIALS AND METHODS Fixed dose combination (FDC) containing rifampicin (450 mg), isoniazid (300 mg), and pyrazinamide (1000 mg) (Rifacept? b.
n. 6007; Concept Pharmaceuticals, Mumbai, India) and Capsule containing C. carvi extract (100 mg) was supplied by Indian Institute of Integrative Medicine (IIIM), Jammu. The preparation and standardization of test material (extraction of C. carvi) was done at IIIM, Jammu, as per the method described and used by Sachin et al., in their animal study evaluating pharmacokinetic interaction of some antitubercular drugs with caraway seeds. High-performance liquid chromatography (HPLC; Shimadzu, Japan) was used to determine the plasma levels of rifampicin, isoniazid, and pyrazinamide. HPLC conditions were Column RP-18, 5 ??m (length 250 ??4 nm); ??max 271nm; mobile phase, 50 mM phosphate buffer (pH 5.0); acetonitrile (60:40).
The flow rate of rifampicin was 0.8 mL/min, whereas for isoniazid and pyrazinamide, it was 0.5 mL/min. The retention times of rifampicin, isoniazid, and pyrazinamide were 5.952, 5.397, and 5.890 min, respectively. No interfering peaks were observed at these retention times. Formulations FDC formulation used in this study was three drug FDC consisting of rifampicin (450 mg), isoniazid (300 mg), and pyrazinamide (1000 mg). This was designated as test formulation-A (TF-A) in the study. Test formulation-B (TF-B) contained the same three drugs FDC and capsule of C. carvi extract (100 mg). Experimental design This was a prospective, two-period, open-label, cross-over experiment on healthy human male volunteers. The study was approved by Institutional Ethics Committee and was conducted in collaboration with IIIM, CSIR, Jammu.
The study was carried out in the Postgraduate Department of Pharmacology and Therapeutics of Govt. Medical College, Jammu. Inclusion criteria Before initiation of study, a group of volunteers was screened by performing physical examination, liver function tests, hemogram, Batimastat lipid profile, renal function tests, chest X-ray, stool and urine selleckchem Idelalisib examination, electrocardiogram, and ultrasonography.