A1R x A2aR x COX

主要研究目的：研究空腹和餐后状态下单次口服受试制剂氨酚咖妥胶囊（规格：布他比妥50mg；对乙酰氨基酚300mg；咖啡因40mg，宜昌人福药业有限责任公司生产）与参比制剂氨酚咖妥胶囊（规格：布他比妥50mg；对乙酰氨基酚300mg；咖啡因40mg；LGM Pharma Solutions, LLC持证）在健康研究参与者体内的药代动力学，评价空腹和餐后状态口服两种制剂的生物等效性。 次要研究目的：研究受试制剂氨酚咖妥胶囊和参比制剂氨酚咖妥胶囊在健康研究参与者中的安全性。

主要研究目的：研究空腹状态下单次口服受试制剂氨酚咖妥胶囊（规格：布他比妥50mg；对乙酰氨基酚300mg；咖啡因40mg，宜昌人福药业有限责任公司生产）与参比制剂氨酚咖妥胶囊（商品名：Fioricet，规格：布他比妥50mg；对乙酰氨基酚300mg；咖啡因40mg；Nexgen Pharma,Inc生产）在健康受试者体内的药代动力学，评价空腹状态口服两种制剂的生物等效性。 次要研究目的：研究受试制剂氨酚咖妥胶囊和参比制剂氨酚咖妥胶囊（Fioricet®）在健康受试者中的安全性。

Researchers are looking for a better way to relieve pain in people, such as after dental surgery.
Participants in this study, have had 3 or 4 third molars (cheek teeth) removed and subsequently have moderate to severe tooth pain.
The study treatment naproxen sodium suppresses inflammatory pain by reducing inflammation.
In the US, naproxen has been marketed since 1976, and naproxen sodium has been approved for over-the-counter (OTC) use since 1994 for the temporary relief of minor aches and pains. Caffeine, which is generally consumed as coffee, tea, or cocoa, has been shown to enhance the effect of various painkillers, and therefore is accepted as an additive.
The main purpose of this study is to learn how well a fixed-dose combination of naproxen sodium and caffeine relieves pain compared to each single ingredient as well as to placebo in participants after molar removal.
A placebo is a treatment that looks like a medicine but does not have any medicine in it.
To answer this, the researchers will compare the amount of pain decrease over 8 hours in participants who received a single dose of either:
1 fixed-dose tablet of naproxen sodium/caffeine
2 fixed-dose tablets of naproxen sodium/caffeine
naproxen sodium only
caffeine only
or placebo The study participants will be randomly (by chance) assigned to one of the five treatment groups. They will take a single dose of two tablets by mouth within 4.5 hours after the surgery. If there is no pain relief within 2 hours after intake, other painkillers may be given.