Clinical trials: Bioequivalence
Healthy
Bioequivalence Study of Risperidone 1 mg Orally-disintegrating Tablets Under Fed Conditions
The purpose of this study is to determine the pharmacokinetics and bioequivalence of Risperidone formulations after administration of single doses to normal, healthy subjects under fed conditions.
- Trial name
- NCT01222923
- Testing
- Risperidone
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy Male Chinese Volunteers
A Study to Investigate the Bioequivalence of Lacosamide 200mg Administered as Intravenous Solution and Oral Tablet in Healthy Chinese Male Subjects
The purpose of this study is to assess the bioequivalence of a 200 mg single dose Lacosamide (LCM) intravenous (iv) solution with a 200 mg single dose LCM oral tablet in healthy Chinese male subjects.
- Trial name
- NCT03204474
- Testing
- Lacosamide (LCM) tablet, Lacosamide (LCM) solution for infusion
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- UCB Biopharma S.P.R.L.
Antithrombic Drug
Bioequivalence Study of Two Products of Apixaban 5mg Tablets in Healthy, Adult, Human Subjects
To compare the bioavailability and characterize the pharmacokinetic profile of the sponsor's test product relative to that of reference product after single oral dose administration in normal, healthy, adult, human subjects under…
- Trial name
- NCT06043297
- Testing
- Apixaban 5MG, Eliquis 5 mg
- Where
- India
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Healthy
Bioequivalence of Two Different Generations of Drug Product of Dabigatran Etexilate Following Oral Administration in Healthy Male and Female Volunteers
The objective was to demonstrate the bioequivalence of capsules made from 2 different drug product batches. The reference batch was representative of the current commercial drug product and of the pivotal Phase III batches.
- Trial name
- NCT02171520
- Testing
- Dabigatran etexilate generation I, Dabigatran etexilate generation II
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Diabetes Mellitus, Type 2
OXEMET™ 1000 mg Coated Tablets (Metformin Hydrochloride) Bioequivalence Study. OXEMET (TM) is a Trademark of the GlaxoSmithKline Group of Companies. GLAFORNIL(TM) is a Trademark of Merck.
This is an open-label, single-center, randomized, 2-way crossover study to evaluate the bioequivalence of OXEMET™ 1000 mg coated tablets, relative to 1000 mg of the reference product administered as two 500 mg tablets, under…
- Trial name
- NCT01842620
- Testing
- Metformin
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Participants
Riluzole Orodispersible Film Replicate Bioavailability
The objective of the study is to compare the pharmacokinetic profile of riluzole after replicate single dose of the novel orodispersible film test formulation and of the marketed reference Rilutek® tablets and to evaluate their…
- Trial name
- NCT04819438
- Testing
- Riluzole 50 mg orodispersible film, Rilutek® 50 mg riluzole tablets
- Where
- Switzerland
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Cross Research S.A.
Healthy
Bioequivalence Test of "Dong-a Bepotastine Besilate Tab" and "Twolion Tab"
An Open-Label, Randomized, 2-sequence, 2-period, Fasted Condition, Single-dose, Per Oral, Cross-over Study to Evaluate the Bioequivalence of "Dong-a Bepotastine Besilate Tab" (Bepotastine Besilate 10mg) and "Twolion Tab"…
- Trial name
- NCT03932435
- Testing
- Fisrt period TWLO_C, Fisrt period TWLO, Washout period
- Where
- South Korea
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Dong-A ST Co., Ltd.
Asthma
Comparison of Salmeterol and Fluticasone Propionate Absorption From Salmeterol/Fluticasone Easyhaler and Seretide Diskus
The purpose of this study is to compare the test product Salmeterol/fluticasone Easyhaler with the reference product Seretide Diskus in terms of drug absorbed in the bloodstream.
- Trial name
- NCT01766843
- Testing
- Seretide Diskus and charcoal, Seretide Diskus, SF Easyhaler and charcoal
- Where
- Finland
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Orion Corporation, Orion Pharma
Healthy
Bioequivalence Study of Loperamide Hydrochloride 2 mg and Simethicone 125 mg Tablet Under Fasting Conditions
The objective of this study is to compare the relative bioavailability of Loperamide HCl 2 mg and simethicone 125 mg tablets (Ranbaxy) with that of Imodium® Advanced caplets (McNeil) in healthy subjects under fasting condition
- Trial name
- NCT00778115
- Testing
- Loperamide HCl 2 mg and simethicone 125 mg tablets
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Single Dose Trial Comparing the Plasma Levels of Two Different Analgesic Transdermal Patch Formulations (Protocol ID 297307)
The purpose of this study is to determine whether the plasma levels of two different analgesic transdermal patch formulations lead to same plasma levels of the active ingredient after single dose application.
- Trial name
- NCT00469404
- Testing
- Buprenorphine
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Grünenthal GmbH
Prostatic Hyperplasia
A Study Assessing a Range of Formulations of the Fixed Dose Combination Product Containing Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) to Find a Formulation Which is Bioequivalent to Harnal-D Tablets (Tamsulosin Hydrochloride, 0.2mg) in Healthy Male Subjects From North East Asia
This study is an open-label, randomized, single dose, multi-stage, cross-over study in healthy male subjects of North East Asian ancestry.
- Trial name
- NCT01495026
- Testing
- Dutasteride (0.5mg, fasted state), Dutasteride (0.5mg, fed state), Fixed dose combination capsule containing dutasteride 0.5mg and tamsulosin 0.2mg (fasted state)
- Where
- Australia
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Bioequivalence Study of Galantamine 4 mg Tablet and Reminyl Following a 4 mg Dose in Healthy Subjects Under Fasting Conditions
The objective of this study was to compare the rate and extent of absorption of Purepac, a subsidiary of Alpharma Inc., U.S.A., galantamine and Janssen Pharmaceutica Products, L.P., U.S.A.
- Trial name
- NCT01190748
- Testing
- Galantamine 4 mg Tablet, single dose, Reminyl 4 mg Tablet, single dose
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Prostate Cancer, Hirsutism
Relative Bioavailability Study of Bicalutamide 50 mg Tablet and Casodex Following a 50 mg Dose in Healthy Subjects Under Fasting Conditions
The purpose of this study is to demonstrate the relative bioavailability of Bicalutamide 50 mg tablet and Casodex following a 50 mg dose in healthy subjects under fasting conditions.
- Trial name
- NCT00959335
- Testing
- Bicalutamide 50 mg Film-Coated Tablets (Casodex) (Astrazeneca Pharmaceutical LP, USA), Bicalutamide 50 mg Film-Coated Tablets (Sandoz Inc., USA)
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Sandoz
Healthy
Bioequivalence of a 2.5 mg Linagliptin / 850 mg Metformin Fixed Dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 850 mg Tablets in Healthy Volunteers
Study to assess bioequivalence of a 2.5 mg linagliptin / 850 mg metformin fixed dose combination (FDC) tablet compared to single tablets of linagliptin 2.5 mg and metformin 850 mg administered together
- Trial name
- NCT02220647
- Testing
- Linagliptin/Metformin FDC, Linagliptin, Metformin
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Parkinson Disease Psychosis
Bioequivalence Study of Pimavanserin 34 mg Capsule
An open-label, balanced, randomized, two treatment, two sequence, two period, two way cross-over, single dose bioequivalence study of Pimavanserin 34 mg Capsule of Humanis Sağlık A.Ş., Turkey and NUPLAZID® (Pimavanserin) capsules…
- Trial name
- NCT06450184
- Testing
- Pimavanserin 34 mg, NUPLAZID 34 MG Oral Capsule
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Infection, Human Immunodeficiency Virus I
A Study to Evaluate the Bioequivalence of a Combined Formulated Tablet Compared With Maraviroc and Combivir™
This is a study in healthy adult subjects to evaluate the bioequivalence of a Combined Formulated Tablet compared with maraviroc and Combivir administered concurrently versus maraviroc + Combivir.
- Trial name
- NCT01597648
- Testing
- Maraviroc, Combivir, GSK2838510
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Bioequivalence Study of Tetrabenazine Tablets 25 mg Under Fed Conditions
This is an open-label, randomized, four-period, two-treatment, two-sequence, balanced, single dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fed conditions.
- Trial name
- NCT03702855
- Testing
- Tetrabenazine Tablets 25 mg
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
A Study on the Bioequivalence of Perindopril Tert-butylamine Tablets Taken on an Empty Stomach in Healthy Subjects
In order to evaluate the bioequivalence of the test preparations and reference preparations of perindopril tert-butylamine tablets after meal and their safety in Chinese adult healthy subjects.
- Trial name
- NCT04556058
- Testing
- Perindopril tert-Butylamine tablets （ Produced by Haisco）, Perindopril tert-Butylamine tablets（ACERTIL®）
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
Fed
Bioequivalence Study of Lamotrigine Tablets 25 mg (2 x 25 mg Tablets) Under Fed Condition
This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover, balanced, single dose pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding…
- Trial name
- NCT01618825
- Testing
- Lamotrigine Tablets 25 mg, Lamotrigine
- Where
- India
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Healthy
Bioequivalence Study of Ranolazine Extended-release Tablets in Healthy Chinese Subjects
The present study was conducted with the objective of comparing the bioequivalence and safety of a single dose of ranolazine extended-release tablets (Test product) manufactured by Haisco Pharmaceutical Group Co., Ltd.
- Trial name
- NCT07054255
- Testing
- Test formulation (Ranolazine extended-release tablets), Reference formulation (Ranolazine extended-release tablets)
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
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