- Natural product: Cannabis (Cannabis sativa)
- Associated study: The effects of cannabinoids on the pharmacokinetics of indinavir and nelfinavir
In Vivo Interaction Study
NFV+THC PK at Baseline and Day 14
No Effect (based on bioequivalence limits) was detected.
NFV = nelfinavir
THC = delta-9-THC
Results
Table 3. Cmax % change reported -17.4 (-43-64). AUC0-8 % change reported -10.2 (-46-92).
| Sample | Compound measured | Value | Measurement | Study sequence | Additional information | N replicates |
|---|
Experimental Conditions
Parallel
Placebo-controlled
Females
Males
No marijuana use
Black or African American
More than one race
White
34
Patient demographics reported include subjects not taking NFV.
Nine subjects' ethnicity is reported as "mixed/other" and is not further specified.
Age (years):
- < 40: 18 (29%)
- 40 - 49: 33 (53%)
- ≥ 50: 11 (18%)
Baseline and day 14: 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 hr post-dose
With meals
Day 14: just prior the second marijuana cigarette; 2, 60 min, 6 hr after smoking
Drug or Natural Product Administration
Oral
Tablet (not specified)
2250 mg
750 mg TID
25 days
Inhalation
Cigarette
Up to 3 cigarettes containing 3.95% delta-9-THC
Up to three times, as tolerated, 1 hr prior to meals
21 days
The National Institute on Drug Abuse
Not specified