- Natural product: Kratom (Mitragyna speciosa)
- Associated study: Clinical Pharmacokinetic Assessment of Kratom (Mitragyna speciosa), a Botanical Product with Opioid-like Effects, in Healthy Adult Participants
In Vivo Pharmacokinetics Study
isopaynantheine
Results
These values are based on the two-compartment model with elimination rate used to describe the median concentration-time profiles of all kratom alkaloids. Data from 5 healthy adults who completed the study (out of 7 enrolled) was used to calculate the results.
| Sample | Compound measured | Value | Measurement | Study sequence | Additional information | N replicates |
|---|
Experimental Conditions
Single dosing
Healthy volunteers
More than one race
7
Seven participants were enrolled. One participant was withdrawn immediately from the study due to nausea and vomiting within 20 minutes of tea consumption. The participant was replaced by another person who experienced nausea and vomiting within 2-3 hours of tea consumption. She continued on with the study, but was withdrawn after 48 hours due to abnormal appearing urine. The six participants identified as White (one male, three females), Black (one male), and multiracial (one male). Participant age ranged from 26-40. None of the participants failed the drug toxicology screening and all participants ceased to consume any concomitant medications, botanicals, and other natural product throughout the duration of the study.
Drug or Natural Product Administration
Oral
Tea
2 grams
Fasted
Fasted overnight prior to study
<10 minutes
Pharmacodynamics (PD) & Adverse Events
Except for the two participants who were withdrawn from the study, none of the other participants experienced any severe adverse events. Two participants experienced adverse events (lightheadedness during blood draw and a mild headache) during the study that was unrelated to kratom use.