NFV+THC PK at Baseline and Day 14 CSV JSON

In Vivo Interaction Study

NFV+THC PK at Baseline and Day 14

No Effect (based on bioequivalence limits) was detected.

nelfinavir

NFV = nelfinavir
THC = delta-9-THC

Results

Table 3. Cmax % change reported -17.4 (-43-64). AUC0-8 % change reported -10.2 (-46-92).

Compound measured Measurement Value Study sequence Additional information N replicates

Experimental Conditions

Parallel
Placebo-controlled

Population

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%)

Pharmacokinetic (PK) Sampling Information

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

Object Administration — nelfinavir

Oral

Tablet (not specified)

2250 mg

750 mg TID

25 days

Precipitant Administration — delta-9-tetrahydrocannabinol (THC)

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

Natural Product Characteristics

The National Institute on Drug Abuse

Not specified