Clinical trials: Sub-healthy
Pain
Bioequivalence Study for Mejoral 500 Product
This will be a monocentric, single blinded, randomized, single-dose, two-periods, two-sequence, crossover bioequivalence study of two oral formulations in healthy participants under fasting conditions.
- Trial name
- NCT02504775
- Testing
- Mejoral® 500 Tablets, Tylenol® Caplets
- Where
- Mexico
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteers
Effect of Sucrose on Liver Fat
AIMS To determine the effect of high and low sucrose diets on liver fat in healthy adult men with liver fat levels below 5%
- Trial name
- NCT02015442
- Testing
- Sucrose
- Where
- United Kingdom
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Healthy
Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor
To investigate the pharmacokinetic and pharmacodynamic interaction of dabigatran and ticagrelor under steady state conditions; to investigate the effect of staggered administration of ticagrelor loading dose on dabigatran…
- Trial name
- NCT01734772
- Testing
- dabigatran etexilate, ticagrelor
- Where
- Germany
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Intestinal Diseases
Bioequivalence Study Between Two Albendazole 400 mg Tablets in Healthy Adult Participants Under Fed Conditions
The goal of this study is to compare two formulations of Albendazole of the same dose in healthy adult participants. Researchers will compare the extent and rate to which the drug is absorbed.
- Trial name
- NCT06201559
- Testing
- Albendazole IP 400 mg, Albendazole 400 mg
- Where
- India
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Ursodiol Tablets 500 mg Under Fasting Conditions
The objective of this study was to evaluate the comparative bioavailability between Ursodiol 500 mg Tablets (test) and Urso Forte™ 500 mg Tablets (reference) after a single-dose in healthy subjects under fasting conditions.
- Trial name
- NCT00909610
- Testing
- Ursodiol, Urso Forte™
- Where
- Canada
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Ondansetron HCl Orally Disintegrating Tablets Under Non-Fasting Conditions
The objective of this study was to compare the relative bioavailability of the test formulation of Ondansetron HCl with the already marketed reference formulation Zofran® ODT under non-fasting conditions in healthy, non-smoking…
- Trial name
- NCT00934921
- Testing
- Ondansetron, Zofran®
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Effect of Slow Release Hydrocortisone on Fed & Fasting Volunteers; Immediate Release on Fasting Only
The purpose of the study is to find out whether food has an effect on the way the body deals with modified release hydrocortisone, and to compare with the pharmacokinetics of immediate release hydrocortisone (fasted).
- Trial name
- NCT02408068
- Testing
- Dexamethasone, Chronocort: fasted, Immediate release hydrocortisone: fasted
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Neurocrine UK Limited
Healthy
Cefdinir for Oral Suspension 250 mg/5mL, Fasting
The objective of this study is to compare the relative bioavailability of cefdinir for oral suspension 250 mg/5mL (manufactured and distributed by TEVA Pharmaceuticals USA) with that of OMNICEF® for oral suspension, 250 mg/5mL…
- Trial name
- NCT00834574
- Testing
- Cefdinir for oral suspension 250 mg/5mL, OMNICEF® for oral suspension 250 mg/5mL
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Meloxicam 15 mg Tablets Under Non-Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of meloxicam from a test formulation Meloxicam 15 mg Tablets versus the reference Mobic® 15 mg Tablets under fed conditions.
- Trial name
- NCT00840879
- Testing
- Meloxicam 15 mg Tablets, Mobic® 15 mg Tablets
- Where
- Canada
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Divalproex Sodium Delayed-Release Tablets Under Non-Fasting Conditions
This study will compare the relative bioavailability of 500 mg Divalproex Sodium Delayed-Release Tablets with that of 500 mg Depakote® Tablets following a single oral dose (1 x 500 mg tablets) in healthy subjects under…
- Trial name
- NCT00834990
- Testing
- divalproex sodium, Depakote®
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Human Immunodeficiency Virus Type 1 (HIV-1)
Bioequivalence Study of Individual Atazanavir and Cobicistat Compared With Atazanavir in Fixed-dose Combination With Cobicistat
The purpose of the study is to compare the pharmacokinetics and bioequivalence of atazanavir in a fixed-dose combination with cobicistat with that of atazanavir coadministered with cobicistat as single agents.
- Trial name
- Atazanavir (NCT01837719)
- Testing
- Atazanavir, Cobicistat, Atazanavir/Cobicistat FDC
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy
Valacyclovir 1000 mg Tablet Under Fed Conditions
The objective of this study was to compare the rate and extent of absorption of Teva Pharmaceuticals USA valacyclovir and GlaxoSmithKline, USA (Valtrex) valacyclovir, administered as 1 x 1000 mg tablet under fed conditions.
- Trial name
- NCT01149460
- Testing
- Valacyclovir
- Where
- Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Doxycycline Monohydrate 25 mg (5mL) Oral Suspension Under Fasting Conditions
The objective of this single-dose, open-label, randomized, two-period crossover study was to compare the rate of absorption and oral bioavailability of a test formulation of doxycycline monohydrate 1 x 25 mg (5mL) oral suspension…
- Trial name
- NCT00829764
- Testing
- Doxycycline Monohydrate
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Prostatic Hyperplasia
SECOTEX® (Tamsulosin Hydrochloride) Bioequivalence Study Brazil - Fast Admin
It will be an open-label, randomized, laboratory-blind, crossover study with 02 treatments, 02 sequences, and 02 periods, in which the healthy male volunteers under fasting conditions receive, in each period, the test formulation…
- Trial name
- NCT01262989
- Testing
- Test formulation, Reference formulation
- Where
- Brazil
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Anti-Psychotic, Management of Manifestations of Psychotic Disorders
Assessment of Intra-subject Variability in the Bioavailability of Chlorpromazine Hydrochloride
Cycle Pharmaceuticals Ltd. (Cycle) is developing an oral tablet formulation of Chlorpromazine Hydrochloride and intends to conduct bioequivalence trials to demonstrate its similarity to the RLD.
- Conditions
- Anti-Psychotic, Management of Manifestations of Psychotic Disorders, Treatment of Schizophrenia, Control Nausea and Vomiting
- Trial name
- NCT02943213
- Testing
- Chlorpromazine Hydrochloride
- Where
- South Africa
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Cycle Pharmaceuticals Ltd.
Infections, Bacterial
Bioequivalence Study Between GR37547 500 Milligrams (mg) Tablet Versus Ciprofloxacin 500 mg Tablet Reference Product in Healthy Adult Subjects
This two-period cross-over study will evaluate bioequivalence of GR37547 (ciprofloxacin 500 mg) tablet versus ciprofloxacin 500 mg reference tablet in healthy adult subjects under fasting conditions.
- Trial name
- NCT03150082
- Testing
- GR37547 tablet, Ciprofloxacin reference tablet
- Where
- South Africa
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Pramipexole Dihydrochloride 0.25 mg Tablets Under Fasting Conditions
The object of this study was to compare the relative bioavailability (rate and extent of absorption) of Pramipexole Dihydrochloride Tablets 0.25 mg by Barr Laboratories, Inc.
- Trial name
- NCT01074450
- Testing
- Pramipexole Dihydrochloride
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Clarithromycin 500 mg Tablets Under Fasting Conditions
This study will compare the relative bioavailability (rate and extent of absorption) of 500 mg Clarithromycin Tablets with that of 500 mg BIAXIN® Tablets following a single oral dose (1 x 500 mg tablet) in healthy adult subjects…
- Trial name
- NCT00835692
- Testing
- Clarithromycin, Biaxin®
- Where
- 2 sites in United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Gastrointestinal Diseases
Bioequivalence Study of Esomeprazole 20 Milligram (mg) Delayed-Release Capsules in Healthy Adult Participants
The purpose of this study is to evaluate bioequivalence parameters of esomeprazole capsules 20 mg (test product) vs. esomeprazole capsules 20 mg (reference product) under fasted conditions.
- Trial name
- NCT05265247
- Testing
- Esomeprazole 20 mg Delayed-Release Capsules, Esomeprazole 20 mg Delayed-Release Capsules (Nexium 24HR)
- Where
- Canada
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- HALEON
Hypertension, Heart Failure
Pivotal Bioequivalence Study to Qualify Manufacturing Site Transfer for Prazosin Hydrochloride Capsules
Prazosin hydrochloride (HCl) is an oral anti-hypertensive indicated for the treatment of primary and secondary hypertension and heart failure. Pfizer Inc.
- Trial name
- NCT04967443
- Testing
- Prazosin HCl 2mg, Prazosin HCl 1 mg, Prazosin HCl 5 mg
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Pfizer