kratom tea - dextromethorphan interaction clinical NPDI study CSV JSON

In Vivo Interaction Study

kratom tea - dextromethorphan interaction clinical NPDI study

No Effect (based on bioequivalence limits) was detected.

dextromethorphan 1119510

  • CYP2D6 4173631

Results

Sample Compound measured Value Measurement Study sequence Additional information N replicates

Experimental Conditions

Fixed-sequence
Single dosing

Population

Females
Healthy volunteers
Males

Asian
Black or African American
White

12

Participants were 6 males and 6 adult females. Females were non-pregnant.

Pharmacokinetic (PK) Sampling Information

0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours

Drug or Natural Product Administration

Object Administration — dextromethorphan

Oral

cocktail

30mg

Single dose

Precipitant Administration — water extract of kratom

Oral

Tea

2g

Single dose

Natural Product Characteristics

Described as Yellow Indonesian Micro Powder - study ID K51

19.48±0.81, 3.18±0.13, 0.647±0.035, 5.12±0.26, 5.86±0.26, 0.512±0.010, and <0.124±0.0014 (below the limit of quantification) mg of mitragynine, speciogynine, mitraciliatine, speciociliatine, paynantheine, isopaynantheine, and 7-hydroxymitragynine, respectively, in each g of dried leaf powder.

2021

Characterization study: Tanna, R.S. et al. Clinical pharmacokinetic assessment of kratom (Mitragyna speciosa), a botanical product with opioid-like effects, in healthy adult participants. Pharmaceutics 14, 620 (2022).

Pharmacodynamics (PD) & Adverse Events

Due to the subtherapeutic dose of midazolam, pharmacodynamic changes were not measured.

The kratom tea and probe drugs were well tolerated by all 12 participants. No participants experienced severe adverse events. Five participtants experienced lightheadedness or headache during at least one arm that did not result in study discontinuation.