In otherwise healthy adults with obesity or overweight, dose-adjusted orforglipron tablets and capsules met AUC bioequivalence criteria across all doses.
In plain wordsIn otherwise healthy adults with obesity or overweight, orforglipron tablets and capsules had equivalent total drug exposure.
- Peptide
- Orforglipron
- Outcome
- No significant changeSteady-state AUC
- Study
n = 429
- Comparator
- Orforglipron capsules
- Analysis
- Primary
- Outcome group
- Pharmacokinetics · Pharmacology
- Studied dose
- Capsules 1, 3, 6, 12, 24, or 36 mg and corresponding tablets 0.8, 2.5, 5.5, 9, 14.5, and 17.2 mg, once daily · oral · 7 days per dose strengthAs given in this study (human).
Source sentences
The 90% confidence interval of the ratios of the geometric least-squares means of AUC0-24,ss and C max,ss between each capsule dose and corresponding tablet dose met the predefined criteria for bioequivalence.
3 context sentences(design, population, supporting numbers)
To evaluate the bioequivalence of orally administered orforglipron tablets and capsules in participants with obesity or overweight who were otherwise healthy.
This phase 1, multicenter, open-label, multiple-dose, dose-escalation study was conducted in 429 healthy adults.
Study participants received each orforglipron capsule and tablet dose strength once daily for 7 days in the fasted state at capsule doses of 1, 3, 6, 12, 24, or 36 mg and corresponding tablet doses of 0.8, 2.5, 5.5, 9, 14.5, and 17.2 mg.