Bioequivalence Study Between Two Oral Formulations of Famotidine Tablets Under Fed Conditions

Perrigo

Status and phase: Completed; Phase 1

Conditions: Bioavailability

Treatments: Drug: Famotidine Tablets, 40 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00803192

40104

Details and patient eligibility

About

Compare the rate and extent of absorption of famotidine 40 mg tablets, administered as 1 x 40 mg tablet under fed conditions.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy men or women 18 years of age or older
• body mass index below 30.0 kg/m2
• willing to participate and sin a copy of the informed consent form

Exclusion criteria

• recent history of drug or alcohol addiction or abuse
• pregnant or lactating women
• history of allergic response to heparin, famotidine, other H2-receptor antagonists, or other related drugs
• evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant
• smoking more than 25 cigarettes per day

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

44 participants in 2 patient groups

Test Drug

Active Comparator group

Treatment:

Drug: Famotidine Tablets, 40 mg

Reference Drug

Active Comparator group

Treatment:

Drug: Famotidine Tablets, 40 mg